Method and apparatus for transcutaneous facial nerve stimulation and applications thereof

ABSTRACT

A system, device, and method for transcutaneous nerve stimulation such as facial nerve stimulation, and in particular, to using transcutaneous nerve stimulation for artificially eliciting eye blink, such as with humans with acute facial paralysis (Bell&#39;s palsy or Dry Eye syndrome), is disclosed. A battery-operated wearable device may employ a pulse generator for periodically and automatically In generating bursts train of asymmetrical Bi-Phasic square pulses. The output pulses are fed to two electrodes that are attached to the skin of the treated person to stimulate the facial nerve for eliciting blinking at a rate that mimics normal blinking operation. The device may include a sensor and a wireless connection, and the parameters of, or the activation of, the generated bursts may be controlled by the sensor output, by human user control, or by data received from the wireless network. Further, the device may transmit status to the wireless network.

RELATED APPLICATIONS

This patent application claims the benefit of U.S. ProvisionalApplication Ser. No. 62/718,773 entitled: “comprehensive eye solutionfor functional impairment of the eye due to facial paralysis” that wasfiled on Aug. 14, 2018, which is incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates generally to an apparatus and method fortranscutaneous nerve stimulation such as facial nerve stimulation, andin particular, but not exclusive, to using non-invasive nervestimulation for artificially eliciting eye blink, such as with humanswith acute facial paralysis.

BACKGROUND

Unless otherwise indicated herein, the materials described in thissection are not prior art to the claims in this application and are notadmitted to be prior art by inclusion in this section. Facial nerve. Thefacial nerve is the seventh cranial nerve, or simply CN VII. It emergesfrom the pons of the brainstem, controls the muscles of facialexpression, and functions in the conveyance of taste sensations from theanterior two-thirds of the tongue. The nerve typically travels from thepons through the facial canal in the temporal bone and exits the skullat the stylomastoid foramen. It arises from the brainstem from an areaposterior to the cranial nerve VI (abducens nerve) and anterior tocranial nerve VIII (vestibulocochlear nerve). The facial nerve alsosupplies preganglionic parasympathetic fibers to several head and neckganglia. The facial and intermediate nerves can be collectively referredto as the nervus intermediofacialis.

The path of the facial nerve can be divided into six segments:intracranial (cisternal) segment, meatal (canalicular) segment (withinthe internal auditory canal), labyrinthine segment (internal auditorycanal to geniculate ganglion), tympanic segment (from geniculateganglion to pyramidal eminence), mastoid segment (from pyramidaleminence to stylomastoid foramen), and extratemporal segment (fromstylomastoid foramen to post parotid branches). The motor part of thefacial nerve arises from the facial nerve nucleus in the pons while thesensory and parasympathetic parts of the facial nerve arise from theintermediate nerve. From the brain stem, the motor and sensory parts ofthe facial nerve join together and traverse the posterior cranial fossabefore entering the petrous temporal bone via the internal auditorymeatus. Upon exiting the internal auditory meatus, the nerve then runs atortuous course through the facial canal, which is divided into thelabyrinthine, tympanic, and mastoid segments.

The labyrinthine segment is very short, and ends where the facial nerveforms a bend known as the geniculum of the facial nerve (“genu” meaningknee), which contains the geniculate ganglion for sensory nerve bodies.The first branch of the facial nerve, the greater superficial petrosalnerve, arises here from the geniculate ganglion. The greater petrosalnerve runs through the pterygoid canal and synapses at thepterygopalatine ganglion. Post synaptic fibers of the greater petrosalnerve innervate the lacrimal gland. In the tympanic segment, the facialnerve runs through the tympanic cavity, medial to the incus. Thepyramidal eminence is the second bend in the facial nerve, where thenerve runs downward as the mastoid segment. In the temporal part of thefacial canal, the nerve gives rise to the stapedius and chorda tympani.The chorda tympani supplies taste fibers to the anterior two thirds ofthe tongue, and also synapses with the submandibular ganglion.Postsynaptic fibers from the submandibular ganglion supply thesublingual and submandibular glands.

Upon emerging from the stylomastoid foramen, the facial nerve gives riseto the posterior auricular branch. The facial nerve then passes throughthe parotid gland, which it does not innervate, to form the parotidplexus, which splits into five branches innervating the muscles offacial expression (temporal, zygomatic, buccal, marginal mandibular,cervical). Facial expression. The main function of the facial nerve ismotor control of all of the muscles of facial expression. It alsoinnervates the posterior belly of the digastric muscle, the stylohyoidmuscle, and the stapedius muscle of the middle ear. All of these musclesare striated muscles of branchiomeric origin developing from the 2ndpharyngeal arch.

Facial sensation. In addition, the facial nerve receives tastesensations from the anterior two-thirds of the tongue via the chordatympani. Taste sensation is sent to the gustatory portion (superiorpart) of the solitary nucleus. General sensation from the anteriortwo-thirds of tongue are supplied by afferent fibers of the thirddivision of the fifth cranial nerve (V-3). These sensory (V-3) and taste(VII) fibers travel together as the lingual nerve briefly before thechorda tympani leaves the lingual nerve to enter the tympanic cavity(middle ear) via the petrotympanic fissure. It joins the rest of thefacial nerve via the canaliculus for chorda tympani. The facial nervethen forms the geniculate ganglion, which contains the cell bodies ofthe taste fibers of chorda tympani and other taste and sensory pathways.From the geniculate ganglion, the taste fibers continue as theintermediate nerve which goes to the upper anterior quadrant of thefundus of the internal acoustic meatus along with the motor root of thefacial nerve. The intermediate nerve reaches the posterior cranial fossavia the internal acoustic meatus before synapsing in the solitarynucleus. The facial nerve also supplies a small amount of afferentinnervation to the oropharynx below the palatine tonsil. There is also asmall amount of cutaneous sensation carried by the nervus intermediusfrom the skin in and around the auricle (outer ear).

Facial nerve paralysis. Facial nerve paralysis is a common problem thatinvolves the paralysis of any structures innervated by the facial nerve.The pathway of the facial nerve is long and relatively convoluted, sothere are a number of causes that may result in facial nerve paralysis.The most common is Bell's palsy, a disease of unknown cause that mayonly be diagnosed by exclusion of identifiable serious causes. Facialnerve paralysis is characterized by facial weakness, usually only in oneside of the face, with other symptoms possibly including loss of taste,hyperacusis and decreased salivation and tear secretion. Other signs maybe linked to the cause of the paralysis, such as vesicles in the ear,which may occur if the facial palsy is due to shingles. Symptoms maydevelop over several hours.

Facial nerve paralysis may be divided into supranuclear and infranuclearlesions. Central facial palsy can be caused by a lacunar infarctaffecting fibers in the internal capsule going to the nucleus. Thefacial nucleus itself can be affected by infarcts of the pontinearteries. These are corticobulbar fibers travelling in internal capsule.Infranuclear lesions refer to the majority of causes of facial palsy

Bell's palsy. Bell's palsy is a type of facial paralysis that results inan inability to control the facial muscles on the affected side.Symptoms can vary from mild to severe. They may include muscletwitching, weakness, or total loss of the ability to move one or rarelyboth sides of the face. Other symptoms include drooping of the eyelid, achange in taste, pain around the ear, and increased sensitivity tosound. Typically, symptoms progress over 48 hours. The symptoms ofBell's palsy are schematically illustrated in the drawing 10 shown inFIG. 1 depicting a person's face, showing a droopy eyelid 11, a chick orfacial paralysis or twitching 12, and a drooping corner 13 of the mouth.

The condition normally gets better by itself with most achieving normalor near-normal function. Corticosteroids have been found to improveoutcomes, while antiviral medications may be of a small additionalbenefit. The eye should be protected from drying up with the use of eyedrops or an eyepatch. Surgery is generally not recommended. Often signsof improvement begin within 14 days, with complete recovery within sixmonths. A few may not recover completely or have a recurrence ofsymptoms. Bell's palsy is the most common cause of one-sided facialnerve paralysis (70%). It occurs in 1 to 4 per 10,000 people per year.About 1.5% of people are affected at some point in their life. It mostcommonly occurs in people between ages 15 and 60. Males and females areaffected equally.

Bell's palsy is characterized by a one-sided facial droop thatprogresses within 72 hours. In rare cases (<1%), it can occur on bothsides resulting in total facial paralysis. The facial nerve controls anumber of functions, such as blinking and closing the eyes, smiling,frowning, lacrimation, salivation, flaring nostrils and raisingeyebrows. It also carries taste sensations from the anterior two-thirdsof the tongue, via the chorda tympani nerve (a branch of the facialnerve). Because of this, people with Bell's palsy may present with lossof taste sensation in the anterior ⅔ of the tongue on the affected side.Although the facial nerve innervates the stapedius muscle of the middleear (via the tympanic branch), sound sensitivity, causing normal soundsto be perceived as very loud, and dysacusis are possible but hardly everclinically evident.

Although defined as a mononeuritis (involving only one nerve), peoplediagnosed with Bell's palsy may have “myriad neurological symptoms”including “facial tingling, moderate or severe headache/neck pain,memory problems, balance problems, ipsilateral limb paresthesia,ipsilateral limb weakness, and a sense of clumsiness” that are“unexplained by facial nerve dysfunction”.

Bell's palsy occurs due to a malfunction of the facial nerve (cranialnerve VII), which controls the muscles of the face. Facial palsy istypified by inability to control movement in the muscles of facialexpression. The paralysis is of the infranuclear/lower motor neurontype. It is thought that as a result of inflammation of the facialnerve, pressure is produced on the nerve where it exits the skull withinits bony canal (the stylomastoid foramen), blocking the transmission ofneural signals or damaging the nerve. Patients with facial palsy forwhich an underlying cause can be found are not considered to have Bell'spalsy per se. Possible causes include tumor, meningitis, stroke,diabetes mellitus, head trauma and inflammatory diseases of the cranialnerves (sarcoidosis, brucellosis, etc.). In these conditions, theneurologic findings are rarely restricted to the facial nerve.

Eye blink. Blinking is a bodily function involving a semi-autonomicrapid closing of the eyelid. A single blink is determined by theforceful closing of the eyelid or inactivation of the levator palpebraesuperioris and the activation of the palpebral portion of theorbicularis oculi, not the full open and close. It is an essentialfunction of the eye that helps spread tears across and remove irritantsfrom the surface of the cornea and conjunctiva. Blinking may have otherfunctions since it occurs more often than necessary just to keep the eyelubricated. Blink speed can be affected by elements such as fatigue, eyeinjury, medication, and disease. The blinking rate is determined by thebody itself, but it can also be affected by external stimulus. Blinkingprovides moisture to the eye by irrigation using tears and a lubricantthe eyes secrete. The eyelid provides suction across the eye from thetear duct to the entire eyeball to keep it from drying out. Blinkingalso protects the eye from irritants. Eyelashes are hairs attached tothe upper and lower eyelids that create a line of defense against dustand other elements to the eye. The eyelashes catch most of theseirritants before they reach the eyeball.

There are multiple muscles that control reflexes of blinking. The mainmuscles, in the upper eyelid, that control the opening and closing arethe orbicularis oculi and levator palpebrae superioris muscle. Theorbicularis oculi closes the eye, while the contraction of the levatorpalpebrae muscle opens the eye. The Muller's muscle, or the superiortarsal muscle, in the upper eyelid and the inferior palpebral muscle inthe lower 3 eyelid are responsible for widening the eyes. These musclesare not only imperative in blinking, but they are also important in manyother functions such as squinting and winking. The inferior palpebralmuscle is coordinated with the inferior rectus to pull down the lowerlid when one looks down.

Though one may think that the stimulus triggering blinking is dry orirritated eyes, it is most likely that it is controlled by a “blinkingcenter” of the globus pallidus of the lenticular nucleus—a body of nervecells between the base and outer surface of the brain. Nevertheless,external stimuli can contribute. The orbicularis oculi is a facialmuscle; therefore its actions are translated by the facial nerve root.The levator palpebrae superioris' action is sent through the oculomotornerve. The duration of a blink is on average 100-150 millisecondsaccording to UCL researcher and between 100-400 ms according to theHarvard Database of Useful Biological Numbers. Closures in excess of1000 ms were defined as microsleeps. Greater activation of dopaminergicpathways dopamine production in the striatum is associated with a higherrate of spontaneous eye blinking. Conditions in which there is reduceddopamine availability such as Parkinson's disease have reduced eye blinkrate, while conditions in which it is raised such as

schizophrenia have an increased rate There are three types of eye blink.Spontaneous blinking which is done without external stimuli and internaleffort. This type of blinking is conducted in the pre-motor brain stemand happens without conscious effort, like breathing and digestion. Areflex blink occurs in response to an external stimulus, such as contactwith the cornea or objects that appear rapidly in front of the eye. Areflex blink is not necessarily a conscious blink either; however itdoes happen faster than a spontaneous blink. Reflex blink may occur inresponse to tactile stimuli (e.g. corneal, eyelash, skin of eyelid,contact with eyebrow), optical stimuli (e.g., dazzle reflex, or menacereflex) or auditory stimuli (e.g., menace reflex). Voluntary blink islarger amplitude than Reflex blink, with the use of all 3 divisions ofthe orbicularis oculi muscle.

Dry Eye Syndrome (DES). Dry eye syndrome (DES), also known askeratoconjunctivitis sicca (KCS), is the condition of having dry eyes.Other associated symptoms include irritation, redness, discharge, andeasily fatigued eyes. Blurred vision may also occur. The symptoms canrange from mild and occasional to severe and continuous. Scarring of thecornea may occur in some cases without treatment. Dry eye occurs wheneither the eye does not produce enough tears or when the tears evaporatetoo quickly. This can result from contact lens use, meibomian glanddysfunction, allergies, pregnancy, Sjögren's syndrome, vitamin Adeficiency, LASIK surgery, and certain medications such asantihistamines, some blood pressure medication, hormone replacementtherapy, and antidepressants. Chronic conjunctivitis such as fromtobacco smoke exposure or infection may also lead to the condition.Diagnosis is mostly based on the symptoms, though a number of othertests may be used. Treatment depends on the underlying cause. Artificialtears are the usual first line treatment. Wrap around glasses that fitclose to the face may decrease tear evaporation. Stopping or changingcertain medications may help. The medication ciclosporin or steroid eyedrops may be used in some cases. Another option is lacrimal plugs thatprevent tears from draining from the surface of the eye. Dry eyesyndrome occasionally makes wearing contact lenses impossible.

Dry eye syndrome is a common eye disease. It affects 5-34% of people tosome degree depending on the population looked at. Among older people itaffects up to 70%. In China it affects about 17% of people. Typicalsymptoms of dry eye syndrome are dryness, burning sensation, and asandy-gritty eye irritation that gets worse as the day goes on. Symptomsmay also be described as itchy, scratchy, stinging or tired eyes. Othersymptoms are pain, redness, a pulling sensation, and pressure behind theeye. There may be a feeling that something, such as a speck of dirt, isin the eye. The resultant damage to the eye surface increases discomfortand sensitivity to bright light. Both eyes usually are affected. Theremay also be a stringy discharge from the eyes. Although it may seemstrange, dry eye can cause the eyes to water. This can happen becausethe eyes are irritated. One may experience excessive tearing in the sameway as one would if something got into the eye. These reflex tears willnot necessarily make the eyes feel better. This is because they are thewatery type that are produced in response to injury, irritation, oremotion. They do not have the lubricating qualities necessary to preventdry eye.

Because blinking coats the eye with tears, symptoms are worsened byactivities in which the rate of blinking is reduced due to prolonged useof the eyes. These activities include prolonged reading, computer usage,driving, or watching television. Symptoms increase in windy, dusty orsmoky (including cigarette smoke) areas, in dry environments highaltitudes including airplanes, on days with low humidity, and in areaswhere an air conditioner (especially in a car), fan, heater, or even ahair dryer is being used. Symptoms reduce during cool, rainy, or foggyweather and in humid places, such as in the shower.

Most people who have dry eyes experience mild irritation with nolong-term effects. However, if the condition is left untreated orbecomes severe, it can produce complications that can cause eye damage,resulting in impaired vision or (rarely) in the loss of vision. Symptomassessment is a key component of dry eye diagnosis—to the extent thatmany believe dry eye syndrome to be a symptom-based disease. Severalquestionnaires have been developed to determine a score that would allowfor dry eye diagnosis. Having dry eyes for a while can lead to tinyabrasions on the surface of the eyes. In advanced cases, the epitheliumundergoes pathologic changes, namely squamous metaplasia and loss ofgoblet cells. Some severe cases result in thickening of the cornealsurface, corneal erosion, punctate keratopathy, epithelial defects,corneal ulceration (sterile and infected), corneal neovascularization,corneal scarring, corneal thinning, and even corneal perforation.Another contributing factor may be lacritin monomer deficiency. Lacritinmonomer, active form of lacritin, is selectively decreased in aqueousdeficient dry eye, Sjögren's syndrome dry eye, contact lens-related dryeye and in blepharitis.

Dry eyes can usually be diagnosed by the symptoms alone. Tests candetermine both the quantity and the quality of the tears. A slit lampexamination can be performed to diagnose dry eyes and to document anydamage to the eye. A Schirmer's test can measure the amount of moisturebathing the eye. This test is useful for determining the severity of thecondition. A five-minute Schirmer's test with and without anesthesiausing a Whatman #41 filter paper 5 mm wide by 35 mm long is performed.For this test, wetting under 5 mm with or without anesthesia isconsidered diagnostic for dry eyes. If the results for the Schirmer'stest are abnormal, a Schirmer II test can be performed to measure reflexsecretion. In this test, the nasal mucosa is irritated with acotton-tipped applicator, after which tear production is measured with aWhatman #41 filter paper. For this test, wetting under 15 mm after fiveminutes is considered abnormal.

A tear breakup time (TBUT) test measures the time it takes for tears tobreak up in the eye. The tear breakup time can be determined afterplacing a drop of fluorescein in the cul-de-sac. A tear protein analysistest measures the lysozyme contained within tears. In tears, lysozymeaccounts for approximately 20 to 40 percent of total protein content. Alactoferrin analysis test provides good correlation with other tests.The presence of the recently described molecule Ap4A, naturallyoccurring in tears, is abnormally high in different states of oculardryness. This molecule can be quantified biochemically simply by takinga tear sample with a plain Schirmer test. Utilizing this technique it ispossible to determine the concentrations of Ap4A in the tears ofpatients and in such way diagnose objectively if the samples areindicative of dry eye.

TENS. Transcutaneous Electrical Nerve Stimulation (TENS or TNS) is theuse of electric current produced by a device to stimulate the nerves fortherapeutic purposes. TENS, by definition, covers the complete range oftranscutaneously applied currents used for nerve excitation although theterm is often used with a more restrictive intent, namely to describethe kind of pulses produced by portable stimulators used to treat pain.The unit is usually connected to the skin using two or more electrodes.A typical battery-operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency(>50 Hz) with an intensity below motor contraction (sensory intensity)or low frequency (<10 Hz) with an intensity that produces motorcontraction.

TENS devices available to the domestic market are used as a non-invasivenerve stimulation intended to reduce both acute and chronic pain. Inprinciple, an adequate intensity of stimulation is necessary to achievepain relief with TENS. An analysis of treatment fidelity (meaning thatthe delivery of TENS in a trial was in accordance with current clinicaladvice, such as using “a strong but comfortable sensation” and suitable,frequent treatment durations) showed that higher fidelity trials tendedto have a positive outcome. A few studies have shown objective evidencethat TENS may modulate or suppress pain signals in the brain.

Various commercial off-the-shelf TENS devices are available in themarket, primarily for providing non-invasive, drug-free method forcontrolling pain, by using electrical impulses sent through the skin tonerves to modify pain perception. Examples for commercially availableTENS devices are the TENS 3000 model sold by Roscoe Medical Inc. (ofMiddleburg Heights, Ohio, U.S.A.), described in the instruction manualentitled: “Instruction Manual for the TENS 3000”, and the TENS 7000model sold by Roscoe Medical Inc. (of Middleburg Heights, Ohio, U.S.A.),described in the instruction manual entitled: “Instruction Manual forthe TENS 7000” (Document Number 42-DT7202_01), downloaded from theInternet on May 2019, which are both incorporated in their entirety forall purposes as if fully set forth herein.

Methods for treating neuropathy and apparatus for use in the methods aredescribed in U.S. Patent Application No. 2005/0234525 to Phillipsentitled: “Electric stimulation for treating neuropathy using asymmetricbiphasic signals”, which is incorporated in its entirety for allpurposes as if fully set forth herein. The apparatus may include acontroller configured to output an asymmetric biphasic signal. Theapparatus can also include a first container and a second container. Thefirst and the second containers can be configured to hold a fluid. Theapparatus may also include a first electrode and a second electrode. Thefirst electrode and the second electrode can be configured to be inelectrical contract with the fluid held by the container, and can beconfigured to be coupled to the controller. The electrodes may beconfigured to receive the asymmetric biphasic signal output from thecontroller.

A transcutaneous electrical nerve-stimulation therapy apparatus andmethod having absolute protection for the patient from shock andautomatic operation are described in U.S. Pat. No. 4,769,881 to Pedigoet al. entitled: “High precision tens apparatus and method of use”,which is incorporated in its entirety for all purposes as if fully setforth herein. The apparatus may operate in three modes, eithercontrolled by timer, operating continuously or put in an automatic modewhere the timer is automatically reset when the probe is removed fromthe patient and then recontacted. A circuit is provided for checking thecontinuity between the patient and the probes before each and everystimulation pulse. These pulses are generated at the same frequency andwith a constant phase shift from the stimulation pulses. At the start ofeach set of stimulation pulses, the pulses are slowly ramped up over a4-5 second interval so as to prevent any initial jolt to the patient.The device may also be used to locate appropriate application points onthe patient's body. The pulses applied are variable current pulseshaving a fixed voltage.

Apparatus for transcutaneous electrical nerve stimulation in humans isdescribed in U.S. Pat. No. 8,948,876 to Gozani et al. entitled:“Apparatus and method for relieving pain using transcutaneous electricalnerve stimulation”, which is incorporated in its entirety for allpurposes as if fully set forth herein. The apparatus comprising ahousing; stimulation means mounted within the housing for electricallystimulating nerves; an electrode array releasably mounted to thehousing, connectable to the stimulation means, and comprising electrodesfor electrical stimulation of nerves; control means mounted to thehousing and electrically connected to the stimulation means forcontrolling the stimulation means; monitoring means mounted to thehousing and electrically connected to the stimulation means formonitoring the stimulation means; user interface means mounted to thehousing and electrically connected to the control means for controllingthe stimulation means; display means mounted to the housing andelectrically connected to the control means and the monitoring means fordisplaying the status of the stimulations means; and a strap attached tothe housing and configured to hold the housing, stimulation means andelectrode array at a specific anatomical location to treat pain.

An electronic stimulating device is disclosed, with the stimulatingdevice particularly illustrated being a transcutaneous nerve stimulating(TENS) device for effecting suppression of pain by nerve fiberstimulation, is described in U.S. Pat. No. 5,069,211 to Bartelt et al.entitled: “Microprocessor controlled electronic stimulating devicehaving biphasic pulse output”, which is incorporated in its entirety forall purposes as if fully set forth herein. Biphasic constant currentoutput pulses are applied to a user through electrode pairsnoninvasively positioned at the skin of the user. Microprocessorgenerated control pulses control generation of the biphasic outputpulses at a biphasic output stage associated with each electrode pair,and the generated biphasic output pulses are capacitively coupled fromeach output stage which also includes a bleeder network for effectingcapacitor discharge. Stimulation may be continuously applied at a levelselected by the user or may be applied in timed varying intensities themaximum level of which is selectable, and displays of intensity andsensed faults, including low battery voltage, are also provided.

EMS. Electrical muscle stimulation (EMS), also known as neuromuscularelectrical stimulation (NMES) or electromyostimulation, is theelicitation of muscle contraction using electric impulses. EMS hasreceived an increasing amount of attention in the last few years formany reasons: it can be utilized as a strength training tool for healthysubjects and athletes; it could be used as a rehabilitation andpreventive tool for partially or totally immobilized patients; it couldbe utilized as a testing tool for evaluating the neural and/or muscularfunction in vivo; it could be used as a post-exercise recovery tool forathletes. The impulses are generated by a device and are deliveredthrough electrodes on the skin near to the muscles being stimulated. Theelectrodes are generally pads that adhere to the skin. The impulsesmimic the action potential that comes from the central nervous system,causing the muscles to contract.

In medicine, EMS is used for rehabilitation purposes, for instance inphysical therapy in the prevention muscle atrophy due to inactivity orneuromuscular imbalance, which can occur for example aftermusculoskeletal injuries (damage to bones, joints, muscles, ligamentsand tendons). This is distinct from Transcutaneous Electrical NerveStimulation (TENS), in which an electric current is used for paintherapy.

Skin electrodes. An electrode is an electrical conductor used to makecontact with a nonmetallic part of a circuit (e.g. a semiconductor, anelectrolyte, a vacuum or air). Skin electrodes are the actual conductivepads attached to the body surface.] Any pair of electrodes can measurethe electrical potential difference between the two correspondinglocations of attachment. Commonly, 10 electrodes attached to the bodyare used to form 12 ECG leads, with each lead measuring a specificelectrical potential difference (as listed in the table below). Twotypes of electrodes in common use are a flat paper-thin sticker and aself-adhesive circular pad. The former are typically used in a singleECG recording while the latter are for continuous recordings as theystick longer. Each electrode consists of an electrically conductiveelectrolyte gel and a silver/silver chloride conductor. The geltypically contains potassium chloride—sometimes silver chloride aswell—to permit electron conduction from the skin to the wire and to theelectrocardiogram.

‘Electronic skin’ electrodes. Flexible, stretchable printed circuitselectrodes (referred to herein as “electronic skin” electrodes) shapedas miniature tattoos are described in an article entitled: “Bionic Skinfor a Cyborg You—Flexible electronics allow us to cover robots andhumans with stretchy sensors” by Takao Someya of the University ofTokyo, Japan, published August 2013 in IEEE Spectrum (downloaded May2019 fromspectrum.ieee.org/biomedical/bionics/bionic-skin-for-a-cyborg-you—precededby https://), which is incorporated in its entirety for all purposes asif fully set forth herein. Such electrodes typically consist of apatterned conductive material printed on an adhesive film that attachesto the skin.

Electromyography is a non-invasive method widely used to map muscleactivation. For decades, it was commonly accepted that dry metallicelectrodes establish poor electrode-skin contact, making themimpractical for skin electromyography applications. Gelled electrodesare therefore the standard in electromyography with their use confined,almost entirely, to laboratory settings. The tattoo electrodes are madeof a conductive material laminated between adhesive polymer films,leaving the electrode ends exposed to be attached to the skin and theconnector end to be attached to a slim connector (ZIF—Zero forceconnector, used to connect flexible printed circuits). This slim ZIFconnector is wired to a signal generator by a flexible cable. Novel dryelectrodes, exhibiting outstanding electromyography recording along withexcellent user comfort, are presented in an article entitled:“Temporary-tattoo for long-term high fidelity biopotential recordings”by Bareket L., Inzelberg L., Rand D., David-Pur M., Rabinovich D.,Brandes B., and Hanein Y. (all of Tel-Aviv University, Tel-Aviv,Israel), published 12 May 2016 on Scientific Reports [6:25727, DOI:10.1038/srep25727], which is incorporated in its entirety for allpurposes as if fully set forth herein. The electrodes were realizedusing screen-printing of carbon ink on a soft support. The conformity ofthe electrodes helps establish direct contact with the skin, making theuse of a gel superfluous. Plasma polymerized 3,4-ethylenedioxythiophenewas used to enhance the impedance of the electrodes. Cyclic voltammetrymeasurements revealed an increase in electrode capacitance by a factorof up to 100 in wet conditions. Impedance measurements show a reductionfactor of 10 in electrode impedance on human skin. The suitability ofthe electrodes for long-term electromyography recordings from the handand from the face is demonstrated. The presented electrodes are ideallysuited for many applications, such as brain-machine interfacing, musclediagnostics, post-injury rehabilitation, and gaming.

An example of an electrode assembly 20 is shown in FIG. 2. The assembly20 includes two electrodes 24 a and 24 b serving as skin patches to beaffixed to a treated human body, connected via respective isolated leads21 a and 21 b to respective exposed leads 23 a and 23 b of the ZIFconnector 22.

EEG Electrodes. EEG electrodes, placed on the scalp, can be either“passive” or “active”. Passive electrodes, which are metallic, areconnected to an amplifier, e.g., by a cable. Active electrodes may havean inbuilt preamplifier to make them less sensitive to environmentalnoise and cable movements. Some types of electrodes may need gel orsaline liquid to operate, in order to reduce the skin-electrode contactimpedance. While other types of EEG electrodes can operate without a gelor saline and are considered “dry electrodes”. There are various brainactivity patterns that may be measured by EEG. Some of the popular onesoften used in affective computing include: Event RelatedDesynchronization/Synchronization, Event Related Potentials (e.g., P30wave and error potentials), and Steady State Evoked Potentials.Measurements of EEG electrodes are typically subjected to variousfeature extraction techniques which aim to represent raw or preprocessedEEG signals by an ideally small number of relevant values, whichdescribe the task-relevant information contained in the signals. Forexample, these features may be the power of the EEG over selectedchannels, and specific frequency bands.

Implantable electrodes. Implantable electrodes are described in apresentation entitled: “Implantable Neural Electrodes—ImplantableElectronics Session” by Dr. Martin Schuettler (of the Laboratory forBiomedical Microtechnology Department of Microsystem EngineeringUniversity of Freiburg, Germany) dated 2012 Mar. 30, and in an articleentitled: “ELECTRODE IMPLANTATION IN THE HUMAN BODY” by Margaret I.Babb, Ph. D. and Anthony M. Dymond, Ph. D. (of Brain InformationService—Brain Research Institute, University of California, Los Angeles,Calif., U.S.A.) published 1974, which are both incorporated in theirentirety for all purposes as if fully set forth herein.

EEG. Electroencephalography (EEG) is an electrophysiological monitoringmethod to record electrical activity of the brain, which is typicallynoninvasive, with the electrodes placed along the scalp, althoughinvasive electrodes are sometimes used in specific applications. EEGmeasures voltage fluctuations resulting from ionic current within theneurons of the brain. In clinical contexts, EEG refers to the recordingof the brain's spontaneous electrical activity over a period, asrecorded from multiple electrodes placed on the scalp. Diagnosticapplications generally focus on the spectral content of EEG, that is,the type of neural oscillations (popularly called “brain waves”) thatcan be observed in EEG signals. Despite limited spatial resolution, EEGcontinues to be a valuable tool for research and diagnosis, especiallywhen millisecond-range temporal resolution (not possible with CT or MRI)is required. Derivatives of the EEG technique include evoked potentials(EP), which involves averaging the EEG activity time-locked to thepresentation of a stimulus of some sort (visual, somatosensory, orauditory). Event-related potentials (ERPs) refer to averaged EEGresponses that are time-locked to more complex processing of stimuli;this technique is used in cognitive science, cognitive psychology, andpsychophysiological research. EEG and measuring EEG are described in anarticle published 2006 in Wiley Encyclopedia of Biomedical Engineeringby Katarzyna Blinowska and Piotr Durka of Warshow University, Waszawa,Poland entitled: “ELECTROENCEPHALOGRAPHY (EEG)”, in an article inMeasurement Science Review (Volume 2, Section 2, 2002) by M. Teplanentitled: “Fundamentals of EEG Measurement”, and in a presentation by M.Kabiraj in Neuroscoences 2003; Vol. 8 Supplement 2, entitled: “EEGCOURSE—Workshop 1—‘Basic principles and interpretations ofelectroencephalography’”, which are all incorporated in their entiretyfor all purposes as if fully set forth herein.

In conventional scalp EEG, the recording is obtained by placingelectrodes on the scalp with a conductive gel or paste, usually afterpreparing the scalp area by light abrasion to reduce impedance due todead skin cells. Many systems typically use electrodes, each of which isattached to an individual wire. Some systems use caps or nets into whichelectrodes are embedded; this is particularly common when high-densityarrays of electrodes are needed. Electrode locations and names arespecified by the International 10-20 system for most clinical andresearch applications (except when high-density arrays are used). Thissystem ensures that the naming of electrodes is consistent acrosslaboratories. In most clinical applications, 19 recording electrodes(plus ground and system reference) are used. A smaller number ofelectrodes are typically used when recording EEG from neonates.Additional electrodes can be added to the standard set-up when aclinical or research application demands increased spatial resolutionfor a particular area of the brain. High-density arrays (typically viacap or net) can contain up to 256 electrodes more-or-less evenly spacedaround the scalp. Each electrode is connected to one input of adifferential amplifier (one amplifier per pair of electrodes); a commonsystem reference electrode is connected to the other input of eachdifferential amplifier. These amplifiers amplify the voltage between theactive electrode and the reference (typically 1,000-100,000 times, or60-100 dB of voltage gain). In analog EEG, the signal is then filtered(next paragraph), and the EEG signal is output as the deflection of pensas paper passes underneath. Most EEG systems these days, however, aredigital, and the amplified signal is digitized via an analog-to-digitalconverter, after being passed through an anti-aliasing filter.Analog-to-digital sampling typically occurs at 256-512 Hz in clinicalscalp EEG; sampling rates of up to 20 kHz are used in some researchapplications.

During the recording, a series of activation procedures may be used.These procedures may induce normal or abnormal EEG activity that mightnot otherwise be seen. These procedures include hyperventilation, photicstimulation (with a strobe light), eye closure, mental activity, sleepand sleep deprivation. During (inpatient) epilepsy monitoring, apatient's typical seizure medications may be withdrawn. The digital EEGsignal is stored electronically and can be filtered for display. Typicalsettings for the high-pass filter and a low-pass filter are 0.5-1 Hz and35-70 Hz, respectively. The high-pass filter typically filters out slowartifact, such as electrogalvanic signals and movement artifact, whereasthe low-pass filter filters out high-frequency artifacts, such aselectromyographic signals. An additional notch filter is typically usedto remove artifact caused by electrical power lines (60 Hz in the UnitedStates and 50 Hz in many other countries). The EEG signal can beprocessed by freely available EEG software such as EEGLAB or theNeurophysiological Biomarker Toolbox.

As part of an evaluation for epilepsy surgery, it may be necessary toinsert electrodes near the surface of the brain, under the surface ofthe dura mater. This is accomplished via burr hole or craniotomy. Thisis referred to variously as “electrocorticography (ECoG)”, “intracranialEEG (I-EEG)” or “subdural EEG (SD-EEG)”. Depth electrodes may also beplaced into brain structures, such as the amygdala or hippocampus,structures, which are common epileptic foci and may not be “seen”clearly by scalp EEG. The electrocorticographic signal is processed inthe same manner as digital scalp EEG (above), with a couple of caveats.ECoG is typically recorded at higher sampling rates than scalp EEGbecause of the requirements of Nyquist theorem—the subdural signal iscomposed of a higher predominance of higher frequency components. Inaddition, many of the artifacts that affect scalp EEG do not affectECoG, and therefore display filtering is often not needed.

A typical adult human EEG signal is about 10 μV to 100 μV in amplitudewhen measured from the scalp and is about 10-20 mV when measured fromsubdural electrodes. Since an EEG voltage signal represents a differencebetween the voltages at two electrodes, the display of the EEG for thereading encephalographer may be set up in one of several ways. Therepresentation of the EEG channels is referred to as a montage.

Internet. The Internet is a global system of interconnected computernetworks that use the standardized Internet Protocol Suite (TCP/IP),including Transmission Control Protocol (TCP) and the Internet Protocol(IP), to serve billions of users worldwide. It is a network of networksthat consists of millions of private, public, academic, business, andgovernment networks, of local to global scope, that are linked by abroad array of electronic and optical networking technologies. TheInternet carries a vast range of information resources and services,such as the interlinked hypertext documents on the World Wide Web (WWW)and the infrastructure to support electronic mail. The Internet backbonerefers to the principal data routes between large, strategicallyinterconnected networks and core routers on the Internet. These datarouters are hosted by commercial, government, academic, and otherhigh-capacity network centers, the Internet exchange points and networkaccess points that interchange Internet traffic between the countries,continents and across the oceans of the world. Traffic interchangebetween Internet service providers (often Tier 1 networks) participatingin the Internet backbone exchange traffic by privately negotiatedinterconnection agreements, primarily governed by the principle ofsettlement-free peering.

The Transmission Control Protocol (TCP) is one of the core protocols ofthe Internet Protocol suite (IP) described in RFC 675 and RFC 793, andthe entire suite is often referred to as TCP/IP. TCP provides reliable,ordered and error-checked delivery of a stream of octets betweenprograms running on computers connected to a local area network,intranet or the public Internet. It resides at the transport layer. Webbrowsers typically use TCP when they connect to servers on the WorldWide Web, and is used to deliver email and transfer files from onelocation to another. HTTP, HTTPS, SMTP, POP3, IMAP, SSH, FTP, Telnet anda variety of other protocols are encapsulated in TCP. As the transportlayer of TCP/IP suite, the TCP provides a communication service at anintermediate level between an application program and the InternetProtocol (IP). Due to network congestion, traffic load balancing, orother unpredictable network behavior, IP packets may be lost,duplicated, or delivered out-of-order. TCP detects these problems,requests retransmission of lost data, rearranges out-of-order data, andeven helps minimize network congestion to reduce the occurrence of theother problems. Once the TCP receiver has reassembled the sequence ofoctets originally transmitted, it passes them to the receivingapplication. Thus, TCP abstracts the application's communication fromthe underlying networking details. The TCP is utilized extensively bymany of the Internet's most popular applications, including the WorldWide Web (WWW), E-mail, File Transfer Protocol, Secure Shell,peer-to-peer file sharing, and some streaming media applications.

While IP layer handles actual delivery of the data, TCP keeps track ofthe individual units of data transmission, called segments, which aredivided smaller pieces of a message, or data for efficient routingthrough the network. For example, when an HTML file is sent from a webserver, the TCP software layer of that server divides the sequence ofoctets of the file into segments and forwards them individually to theIP software layer (Internet Layer). The Internet Layer encapsulates eachTCP segment into an IP packet by adding a header that includes (amongother data) the destination IP address. When the client program on thedestination computer receives them, the TCP layer (Transport Layer)reassembles the individual segments and ensures they are correctlyordered and error-free as it streams them to an application.

The TCP protocol operations may be divided into three phases. First, theconnections must be properly established in a multi-step handshakeprocess (connection establishment) before entering the data transferphase. After data transmission is completed, the connection terminationcloses established virtual circuits and releases all allocatedresources. A TCP connection is typically managed by an operating systemthrough a programming interface that represents the local end-point forcommunications, the Internet socket. The local end-point undergoes aseries of state changes throughout the duration of a TCP connection.

The Internet Protocol (IP) is the principal communications protocol usedfor relaying datagrams (packets) across a network using the InternetProtocol Suite. It is considered as the primary protocol thatestablishes the Internet, and is responsible for routing packets acrossthe network boundaries. IP is the primary protocol in the Internet Layerof the Internet Protocol Suite and has the task of delivering datagramsfrom the source host to the destination host based on their addresses.For this purpose, IP defines addressing methods and structures fordatagram encapsulation. Internet Protocol Version 4 (IPv4) is thedominant protocol of the Internet. IPv4 is described in InternetEngineering Task Force (IETF) Request for Comments (RFC) 791 and RFC1349, and the successor, Internet Protocol Version 6 (IPv6), iscurrently active and in growing deployment worldwide. IPv4 uses 32-bitaddresses (providing 4 billion: 4.3×10⁹ addresses), while IPv6 uses128-bit addresses (providing 340 undecillion or 3.4×10³⁸ addresses), asdescribed in RFC 2460.

The Internet architecture employs a client-server model, among otherarrangements. The terms ‘server’ or ‘server computer’ relates herein toa device or computer (or a plurality of computers) connected to theInternet, and is used for providing facilities or services to othercomputers or other devices (referred to in this context as ‘clients’)connected to the Internet. A server is commonly a host that has an IPaddress and executes a ‘server program’, and typically operates as asocket listener. Many servers have dedicated functionality such as webserver, Domain Name System (DNS) server (described in RFC 1034 and RFC1035), Dynamic Host Configuration Protocol (DHCP) server (described inRFC 2131 and RFC 3315), mail server, File Transfer Protocol (FTP) serverand database server. Similarly, the term ‘client’ is used herein toinclude, but not limited to, a program or a device, or a computer (or aseries of computers) executing this program, which accesses a serverover the Internet for a service or a resource. Clients commonly initiateconnections that a server may accept. For non-limiting example, webbrowsers are clients that connect to web servers for retrieving webpages, and email clients connect to mail storage servers for retrievingmails.

Wireless. Any embodiment herein may be used in conjunction with one ormore types of wireless communication signals and/or systems, forexample, Radio Frequency (RF), Infra Red (IR), Frequency-DivisionMultiplexing (FDM), Orthogonal FDM (OFDM), Time-Division Multiplexing(TDM), Time-Division Multiple Access (TDMA), Extended TDMA (E-TDMA),General Packet Radio Service (GPRS), extended GPRS, Code-DivisionMultiple Access (CDMA), Wideband CDMA (WCDMA), CDMA 2000, single-carrierCDMA, multi-carrier CDMA, Multi-Carrier Modulation (MDM), DiscreteMulti-Tone (DMT), Bluetooth (RTM), Global Positioning System (GPS),Wi-Fi, Wi-Max, ZigBee (TM), Ultra-Wideband (UWB), Global System forMobile communication (GSM), 2G, 2.5G, 3G, 3.5G, Enhanced Data rates forGSM Evolution (EDGE), or the like. Any wireless network or wirelessconnection herein may be operating substantially in accordance withexisting IEEE 802.11, 802.11a, 802.11b, 802.11g, 802.11k, 802.11n,802.11r, 802.16, 802.16d, 802.16e, 802.20, 802.21 standards and/orfuture versions and/or derivatives of the above standards. Further, anetwork element (or a device) herein may consist of, be part of, orinclude, a cellular radio-telephone communication system, a cellulartelephone, a wireless telephone, a Personal Communication Systems (PCS)device, a PDA device that incorporates a wireless communication device,or a mobile/portable Global Positioning System (GPS) device. Further, awireless communication may be based on wireless technologies that aredescribed in Chapter 20: “Wireless Technologies” of the publicationnumber 1-587005-001-3 by Cisco Systems, Inc. (7/99) entitled:“Internetworking Technologies Handbook”, which is incorporated in itsentirety for all purposes as if fully set forth herein. Wirelesstechnologies and networks are further described in a book published 2005by Pearson Education, Inc. William Stallings [ISBN: 0-13-191835-4]entitled: “Wireless Communications and Networks—second Edition”, whichis incorporated in its entirety for all purposes as if fully set forthherein.

Wireless networking typically employs an antenna (a.k.a. aerial), whichis an electrical device that converts electric power into radio waves,and vice versa, connected to a wireless radio transceiver. Intransmission, a radio transmitter supplies an electric currentoscillating at radio frequency to the antenna terminals, and the antennaradiates the energy from the current as electromagnetic waves (radiowaves). In reception, an antenna intercepts some of the power of anelectromagnetic wave in order to produce a low voltage at its terminalsthat is applied to a receiver to be amplified. Typically an antennaconsists of an arrangement of metallic conductors (elements),electrically connected (often through a transmission line) to thereceiver or transmitter. An oscillating current of electrons forcedthrough the antenna by a transmitter will create an oscillating magneticfield around the antenna elements, while the charge of the electronsalso creates an oscillating electric field along the elements. Thesetime-varying fields radiate away from the antenna into space as a movingtransverse electromagnetic field wave. Conversely, during reception, theoscillating electric and magnetic fields of an incoming radio wave exertforce on the electrons in the antenna elements, causing them to moveback and forth, creating oscillating currents in the antenna. Antennascan be designed to transmit and receive radio waves in all horizontaldirections equally (omnidirectional antennas), or preferentially in aparticular direction (directional or high gain antennas). In the lattercase, an antenna may also include additional elements or surfaces withno electrical connection to the transmitter or receiver, such asparasitic elements, parabolic reflectors or horns, which serve to directthe radio waves into a beam or other desired radiation pattern.

ISM. The Industrial, Scientific and Medical (ISM) radio bands are radiobands (portions of the radio spectrum) reserved internationally for theuse of radio frequency (RF) energy for industrial, scientific andmedical purposes other than telecommunications. In general,communications equipment operating in these bands must tolerate anyinterference generated by ISM equipment, and users have no regulatoryprotection from ISM device operation. The ISM bands are defined by theITU-R in 5.138, 5.150, and 5.280 of the Radio Regulations. Individualcountries use of the bands designated in these sections may differ dueto variations in national radio regulations. Because communicationdevices using the ISM bands must tolerate any interference from ISMequipment, unlicensed operations are typically permitted to use thesebands, since unlicensed operation typically needs to be tolerant ofinterference from other devices anyway. The ISM bands share allocationswith unlicensed and licensed operations; however, due to the highlikelihood of harmful interference, licensed use of the bands istypically low. In the United States, uses of the ISM bands are governedby Part 18 of the Federal Communications Commission (FCC) rules, whilePart 15 contains the rules for unlicensed communication devices, eventhose that share ISM frequencies. In Europe, the ETSI is responsible forgoverning ISM bands.

Commonly used ISM bands include a 2.45 GHz band (also known as 2.4 GHzband) that includes the frequency band between 2.400 GHz and 2.500 GHz,a 5.8 GHz band that includes the frequency band 5.725-5.875 GHz, a 24GHz band that includes the frequency band 24.000-24.250 GHz, a 61 GHzband that includes the frequency band 61.000-61.500 GHz, a 122 GHz bandthat includes the frequency band 122.000-123.000 GHz, and a 244 GHz bandthat includes the frequency band 244.000-246.000 GHz.

ZigBee. ZigBee is a standard for a suite of high-level communicationprotocols using small, low-power digital radios based on an IEEE 802standard for Personal Area Network (PAN). Applications include wirelesslight switches, electrical meters with in-home-displays, and otherconsumer and industrial equipment that require a short-range wirelesstransfer of data at relatively low rates. The technology defined by theZigBee specification is intended to be simpler and less expensive thanother WPANs, such as Bluetooth. ZigBee is targeted at Radio-Frequency(RF) applications that require a low data rate, long battery life, andsecure networking. ZigBee has a defined rate of 250 kbps suited forperiodic or intermittent data or a single signal transmission from asensor or input device.

ZigBee builds upon the physical layer and medium access control definedin IEEE standard 802.15.4 (2003 version) for low-rate WPANs. Thespecification further discloses four main components: network layer,application layer, ZigBee Device Objects (ZDOs), andmanufacturer-defined application objects, which allow for customizationand favor total integration. The ZDOs are responsible for a number oftasks, which include keeping of device roles, management of requests tojoin a network, device discovery, and security. Because ZigBee nodes cango from a sleep to active mode in 30 ms or less, the latency can be lowand devices can be responsive, particularly compared to Bluetoothwake-up delays, which are typically around three seconds. ZigBee nodescan sleep most of the time, thus the average power consumption can belower, resulting in longer battery life.

There are three defined types of ZigBee devices: ZigBee Coordinator(ZC), ZigBee Router (ZR), and ZigBee End Device (ZED). ZigBeeCoordinator (ZC) is the most capable device and forms the root of thenetwork tree and might bridge to other networks. There is exactly onedefined ZigBee coordinator in each network, since it is the device thatstarted the network originally. It is able to store information aboutthe network, including acting as the Trust Center & repository forsecurity keys. ZigBee Router (ZR) may be running an application functionas well as may be acting as an intermediate router, passing on data fromother devices. ZigBee End Device (ZED) contains functionality to talk toa parent node (either the coordinator or a router). This relationshipallows the node to be asleep a significant amount of the time, therebygiving long battery life. A ZED requires the least amount of memory, andtherefore can be less expensive to manufacture than a ZR or ZC.

The protocols build on recent algorithmic research (Ad-hoc On-demandDistance Vector, neuRFon) to automatically construct a low-speed ad-hocnetwork of nodes. In most large network instances, the network will be acluster of clusters. It can also form a mesh or a single cluster. Thecurrent ZigBee protocols support beacon and non-beacon enabled networks.In non-beacon-enabled networks, an unslotted CSMA/CA channel accessmechanism is used. In this type of network, ZigBee Routers typicallyhave their receivers continuously active, requiring a more robust powersupply. However, this allows for heterogeneous networks in which somedevices receive continuously, while others only transmit when anexternal stimulus is detected.

In beacon-enabled networks, the special network nodes called ZigBeeRouters transmit periodic beacons to confirm their presence to othernetwork nodes. Nodes may sleep between the beacons, thus lowering theirduty cycle and extending their battery life. Beacon intervals depend onthe data rate; they may range from 15.36 milliseconds to 251.65824seconds at 250 Kbit/s, from 24 milliseconds to 393.216 seconds at 40kbit/s, and from 48 milliseconds to 786.432 seconds at 20 kbit/s. Ingeneral, the ZigBee protocols minimize the time the radio is on toreduce power consumption. In beaconing networks, nodes only need to beactive while a beacon is being transmitted. In non-beacon-enablednetworks, power consumption is decidedly asymmetrical: some devices arealways active while others spend most of their time sleeping. Except forthe Smart Energy Profile 2.0, current ZigBee devices conform to the IEEE802.15.4-2003 Low-Rate Wireless Personal Area Network (LR-WPAN)standard. The standard specifies the lower protocol layers—the PHYsicallayer (PHY), and the Media Access Control (MAC) portion of the Data LinkLayer (DLL). The basic channel access mode is “Carrier Sense, MultipleAccess/Collision Avoidance” (CSMA/CA), that is, the nodes talk in thesame way that people converse; they briefly check to see that no one istalking before they start. There are three notable exceptions to the useof CSMA. Beacons are sent on a fixed time schedule, and do not use CSMA.Message acknowledgments also do not use CSMA. Finally, devices in BeaconOriented networks that have low latency real-time requirement, may alsouse Guaranteed Time Slots (GTS), which by definition do not use CSMA.

Z-Wave. Z-Wave is a wireless communications protocol by the Z-WaveAlliance (http://www.z-wave.com) designed for home automation,specifically for remote control applications in residential and lightcommercial environments. The technology uses a low-power RF radioembedded or retrofitted into home electronics devices and systems, suchas lighting, home access control, entertainment systems and householdappliances. Z-Wave communicates using a low-power wireless technologydesigned specifically for remote control applications. Z-Wave operatesin the sub-gigahertz frequency range, around 900 MHz. This band competeswith some cordless telephones and other consumer electronics devices,but avoids interference with WiFi and other systems that operate on thecrowded 2.4 GHz band. Z-Wave is designed to be easily embedded inconsumer electronics products, including battery-operated devices suchas remote controls, smoke alarms, and security sensors.

Z-Wave is a mesh networking technology where each node or device on thenetwork is capable of sending and receiving control commands throughwalls or floors, and use intermediate nodes to route around householdobstacles or radio dead spots that might occur in the home. Z-Wavedevices can work individually or in groups, and can be programmed intoscenes or events that trigger multiple devices, either automatically orvia remote control. The Z-wave radio specifications include bandwidth of9,600 bit/s or 40 kbit/s, fully interoperable, GFSK modulation, and arange of approximately 100 feet (or 30 meters) assuming “open air”conditions, with reduced range indoors depending on building materials,etc. The Z-Wave radio uses the 900 MHz ISM band: 908.42 MHz (UnitedStates); 868.42 MHz (Europe); 919.82 MHz (Hong Kong); and 921.42 MHz(Australia/New Zealand).

Z-Wave uses a source-routed mesh network topology and has one or moremaster controllers that control routing and security. The devices cancommunicate to another by using intermediate nodes to actively routearound, and circumvent household obstacles or radio dead spots thatmight occur. A message from node A to node C can be successfullydelivered even if the two nodes are not within range, providing that athird node B can communicate with nodes A and C. If the preferred routeis unavailable, the message originator will attempt other routes until apath is found to the “C” node. Therefore, a Z-Wave network can span muchfarther than the radio range of a single unit; however, with several ofthese hops, a delay may be introduced between the control command andthe desired result. In order for Z-Wave units to be able to routeunsolicited messages, they cannot be in sleep mode. Therefore, mostbattery-operated devices are not designed as repeater units. A Z-Wavenetwork can consist of up to 232 devices with the option of bridgingnetworks if more devices are required.

WWAN. Any wireless network herein may be a Wireless Wide Area Network(WWAN) such as a wireless broadband network, and the WWAN port may be anantenna and the WWAN transceiver may be a wireless modem. The wirelessnetwork may be a satellite network, the antenna may be a satelliteantenna, and the wireless modem may be a satellite modem. The wirelessnetwork may be a WiMAX network such as according to, compatible with, orbased on, IEEE 802.16-2009, the antenna may be a WiMAX antenna, and thewireless modem may be a WiMAX modem. The wireless network may be acellular telephone network, the antenna may be a cellular antenna, andthe wireless modem may be a cellular modem. The cellular telephonenetwork may be a Third Generation (3G) network, and may use UMTS W-CDMA,UMTS HSPA, UMTS TDD, CDMA2000 1xRTT, CDMA2000 EV-DO, or GSMEDGE-Evolution. The cellular telephone network may be a FourthGeneration (4G) network and may use or be compatible with HSPA+, MobileWiMAX, LTE, LTE-Advanced, MBWA, or may be compatible with, or based on,IEEE 802.20-2008.

WLAN. Wireless Local Area Network (WLAN), is a popular wirelesstechnology that makes use of the Industrial, Scientific and Medical(ISM) frequency spectrum. In the US, three of the bands within the ISMspectrum are the A band, 902-928 MHz; the B band, 2.4-2.484 GHz (a.k.a.2.4 GHz); and the C band, 5.725-5.875 GHz (a.k.a. 5 GHz). Overlappingand/or similar bands are used in different regions such as Europe andJapan. In order to allow interoperability between equipment manufacturedby different vendors, few WLAN standards have evolved, as part of theIEEE 802.11 standard group, branded as WiFi (www.wi-fi.org). IEEE802.11b describes a communication using the 2.4 GHz frequency band andsupporting communication rate of 11 Mb/s, IEEE 802.11a uses the 5 GHzfrequency band to carry 54 MB/s and IEEE 802.11g uses the 2.4 GHz bandto support 54 Mb/s. The WiFi technology is further described in apublication entitled: “WiFi Technology” by Telecom Regulatory Authority,published on July 2003, which is incorporated in its entirety for allpurposes as if fully set forth herein. The IEEE 802 defines an ad-hocconnection between two or more devices without using a wireless accesspoint: the devices communicate directly when in range. An ad hoc networkoffers peer-to-peer layout and is commonly used in situations such as aquick data exchange or a multiplayer LAN game, because the setup is easyand an access point is not required.

A node/client with a WLAN interface is commonly referred to as STA(Wireless Station/Wireless client). The STA functionality may beembedded as part of the data unit, or alternatively be a dedicated unit,referred to as bridge, coupled to the data unit. While STAs maycommunicate without any additional hardware (ad-hoc mode), such networkusually involves Wireless Access Point (a.k.a. WAP or AP) as a mediationdevice. The WAP implements the Basic Stations Set (BSS) and/or ad-hocmode based on Independent BSS (IBSS). STA, client, bridge and WAP willbe collectively referred to hereon as WLAN unit. Bandwidth allocationfor IEEE 802.11g wireless in the U.S. allows multiple communicationsessions to take place simultaneously, where eleven overlapping channelsare defined spaced 5 MHz apart, spanning from 2412 MHz as the centerfrequency for channel number 1, via channel 2 centered at 2417 MHz and2457 MHz as the center frequency for channel number 10, up to channel 11centered at 2462 MHz. Each channel bandwidth is 22 MHz, symmetrically(+/−11 MHz) located around the center frequency. In the transmissionpath, first the baseband signal (IF) is generated based on the data tobe transmitted, using 256 QAM (Quadrature Amplitude Modulation) basedOFDM (Orthogonal Frequency Division Multiplexing) modulation technique,resulting a 22 MHz (single channel wide) frequency band signal. Thesignal is then up converted to the 2.4 GHz (RF) and placed in the centerfrequency of required channel, and transmitted to the air via theantenna. Similarly, the receiving path comprises a received channel inthe RF spectrum, down converted to the baseband (IF) wherein the data isthen extracted.

In order to support multiple devices and using a permanent solution, aWireless Access Point (WAP) is typically used. A Wireless Access Point(WAP, or Access Point—AP) is a device that allows wireless devices toconnect to a wired network using Wi-Fi, or related standards. The WAPusually connects to a router (via a wired network) as a standalonedevice, but can also be an integral component of the router itself.Using Wireless Access Point (AP) allows users to add devices that accessthe network with little or no cables. A WAP normally connects directlyto a wired Ethernet connection, and the AP then provides wirelessconnections using radio frequency links for other devices to utilizethat wired connection. Most APs support the connection of multiplewireless devices to one wired connection. Wireless access typicallyinvolves special security considerations, since any device within arange of the WAP can attach to the network. The most common solution iswireless traffic encryption. Modern access points come with built-inencryption such as Wired Equivalent Privacy (WEP) and Wi-Fi ProtectedAccess (WPA), typically used with a password or a passphrase.Authentication in general, and a WAP authentication in particular, isused as the basis for authorization, which determines whether aprivilege may be granted to a particular user or process, privacy, whichkeeps information from becoming known to non-participants, andnon-repudiation, which is the inability to deny having done somethingthat was authorized to be done based on the authentication. Anauthentication in general, and a WAP authentication in particular, mayuse an authentication server that provides a network service thatapplications may use to authenticate the credentials, usually accountnames and passwords of their users. When a client submits a valid set ofcredentials, it receives a cryptographic ticket that it can subsequentlybe used to access various services. Authentication algorithms includepasswords, Kerberos, and public key encryption.

Prior art technologies for data networking may be based on singlecarrier modulation techniques, such as AM (Amplitude Modulation), FM(Frequency Modulation), and PM (Phase Modulation), as well as bitencoding techniques such as QAM (Quadrature Amplitude Modulation) andQPSK (Quadrature Phase Shift Keying). Spread spectrum technologies, toinclude both DSSS (Direct Sequence Spread Spectrum) and FHSS (FrequencyHopping Spread Spectrum) are known in the art. Spread spectrum commonlyemploys Multi-Carrier Modulation (MCM) such as OFDM (OrthogonalFrequency Division Multiplexing). OFDM and other spread spectrum arecommonly used in wireless communication systems, particularly in WLANnetworks.

BAN. A wireless network may be a Body Area Network (BAN) according to,or based on, IEEE 802.15.6 standard, and communicating devices maycomprise a BAN interface that may include a BAN port and a BANtransceiver. The BAN may be a Wireless BAN (WBAN), and the BAN port maybe an antenna and the BAN transceiver may be a WBAN modem. Bluetooth.Bluetooth is a wireless technology standard for exchanging data overshort distances (using short-wavelength UHF radio waves in the ISM bandfrom 2.4 to 2.485 GHz) from fixed and mobile devices, and buildingpersonal area networks (PANs). It can connect several devices,overcoming problems of synchronization. A Personal Area Network (PAN)may be according to, compatible with, or based on, Bluetooth™ or IEEE802.15.1-2005 standard. A Bluetooth controlled electrical appliance isdescribed in U.S. Patent Application No. 2014/0159877 to Huang entitled:“Bluetooth Controllable Electrical Appliance”, and an electric powersupply is described in U.S. Patent Application No. 2014/0070613 to Garbet al. entitled: “Electric Power Supply and Related Methods”, which areboth incorporated in their entirety for all purposes as if fully setforth herein. Any Personal Area Network (PAN) may be according to,compatible with, or based on, Bluetooth™ or IEEE 802.15.1-2005 standard.A Bluetooth controlled electrical appliance is described in U.S. PatentApplication No. 2014/0159877 to Huang entitled: “Bluetooth ControllableElectrical Appliance”, and an electric power supply is described in U.S.Patent Application No. 2014/0070613 to Garb et al. entitled: “ElectricPower Supply and Related Methods”, which are both incorporated in theirentirety for all purposes as if fully set forth herein.

Bluetooth operates at frequencies between 2402 and 2480 MHz, or 2400 and2483.5 MHz including guard bands 2 MHz wide at the bottom end and 3.5MHz wide at the top. This is in the globally unlicensed (but notunregulated) Industrial, Scientific and Medical (ISM) 2.4 GHzshort-range radio frequency band. Bluetooth uses a radio technologycalled frequency-hopping spread spectrum. Bluetooth divides transmitteddata into packets, and transmits each packet on one of 79 designatedBluetooth channels. Each channel has a bandwidth of 1 MHz. It usuallyperforms 800 hops per second, with Adaptive Frequency-Hopping (AFH)enabled. Bluetooth low energy uses 2 MHz spacing, which accommodates 40channels. Bluetooth is a packet-based protocol with a master-slavestructure. One master may communicate with up to seven slaves in apiconet. All devices share the master's clock. Packet exchange is basedon the basic clock, defined by the master, which ticks at 312.5 μsintervals. Two clock ticks make up a slot of 625 μs, and two slots makeup a slot pair of 1250 μs. In the simple case of single-slot packets themaster transmits in even slots and receives in odd slots. The slave,conversely, receives in even slots and transmits in odd slots. Packetsmay be 1, 3 or 5 slots long, but in all cases the master's transmissionbegins in even slots and the slave's in odd slots.

A master Bluetooth device can communicate with a maximum of sevendevices in a piconet (an ad-hoc computer network using Bluetoothtechnology), though not all devices reach this maximum. The devices canswitch roles, by agreement, and the slave can become the master (forexample, a headset initiating a connection to a phone necessarily beginsas master—as initiator of the connection—but may subsequently operate asslave). The Bluetooth Core Specification provides for the connection oftwo or more piconets to form a scatternet, in which certain devicessimultaneously play the master role in one piconet and the slave role inanother. At any given time, data can be transferred between the masterand one other device (except for the little-used broadcast mode). Themaster chooses which slave device to address; typically, it switchesrapidly from one device to another in a round-robin fashion. Since it isthe master that chooses which slave to address, whereas a slave issupposed to listen in each receive slot, being a master is a lighterburden than being a slave. Being a master of seven slaves is possible;being a slave of more than one master is difficult.

Bluetooth Low Energy. Bluetooth low energy (Bluetooth LE, BLE, marketedas Bluetooth Smart) is a wireless personal area network technologydesigned and marketed by the Bluetooth Special Interest Group (SIG)aimed at novel applications in the healthcare, fitness, beacons,security, and home entertainment industries. Compared to ClassicBluetooth, Bluetooth Smart is intended to provide considerably reducedpower consumption and cost while maintaining a similar communicationrange. Bluetooth low energy is described in a Bluetooth SIG publishedDec. 2, 2014 standard Covered Core Package version: 4.2, entitled:“Master Table of Contents & Compliance Requirements—Specification Volume0”, and in an article published 2012 in Sensors [ISSN 1424-8220] byCaries Gomez et al. [Sensors 2012, 12, 11734-11753;doi:10.3390/s120211734] entitled: “Overview and Evaluation of BluetoothLow Energy: An Emerging Low-Power Wireless Technology”, which are bothincorporated in their entirety for all purposes as if fully set forthherein.

Bluetooth Smart technology operates in the same spectrum range (the2.400 GHz-2.4835 GHz ISM band) as Classic Bluetooth technology, but usesa different set of channels. Instead of the Classic Bluetooth 79 1-MHzchannels, Bluetooth Smart has 40 2-MHz channels. Within a channel, datais transmitted using Gaussian frequency shift modulation, similar toClassic Bluetooth's Basic Rate scheme. The bit rate is 1 Mbit/s, and themaximum transmit power is 10 mW. Bluetooth Smart uses frequency hoppingto counteract narrowband interference problems. Classic Bluetooth alsouses frequency hopping but the details are different; as a result, whileboth FCC and ETSI classify Bluetooth technology as an FHSS scheme,Bluetooth Smart is classified as a system using digital modulationtechniques or a direct-sequence spread spectrum. All Bluetooth Smartdevices use the Generic Attribute Profile (GATT). The applicationprogramming interface offered by a Bluetooth Smart aware operatingsystem will typically be based around GATT concepts.

WMN. A Wireless Mesh Network (WMN) and Wireless Distribution Systems(WDS) are known in the art to be a communication network made up ofclients, mesh routers and gateways organized in a mesh topology andconnected using radio. Such wireless networks may be based on DSR as therouting protocol. WMNs are standardized in IEEE 802.11s and described ina slide-show by W. Steven Conner, Intel Corp. et al. entitled: “IEEE802.11s Tutorial” presented at the IEEE 802 Plenary, Dallas on Nov. 13,2006, in a slide-show by Eugen Borcoci of University PolitehnicaBucharest, entitled: “Wireless Mesh Networks Technologies:Architectures, Protocols, Resource Management and Applications”,presented in INFOWARE Conference on Aug. 22-29 2009 in Cannes, France,and in an IEEE Communication magazine paper by Joseph D. Camp and EdwardW. Knightly of Electrical and Computer Engineering, Rice University,Houston, Tex., USA, entitled: “The IEEE 802.11s Extended Service SetMesh Networking Standard”, which are incorporated in their entirety forall purposes as if fully set forth herein. The arrangement describedherein can be equally applied to such wireless networks, wherein twoclients exchange information using different paths by using mesh routersas intermediate and relay servers. Commonly in wireless networks, therouting is based on MAC addresses. Hence, the above discussion relatingto IP addresses applies in such networks to using the MAC addresses foridentifying the client originating the message, the mesh routers (orgateways) serving as the relay servers, and the client serving as theultimate destination computer.

Cellular. Cellular telephone network may be according to, compatiblewith, or may be based on, a Third Generation (3G) network that uses UMTSW-CDMA, UMTS HSPA, UMTS TDD, CDMA2000 1xRTT, CDMA2000 EV-DO, or GSMEDGE-Evolution. The cellular telephone network may be a FourthGeneration (4G) network that uses HSPA+, Mobile WiMAX, LTE,LTE-Advanced, MBWA, or may be based on or compatible with IEEE802.20-2008.

NFC. Any wireless communication herein may be partly or in full inaccordance with, or based on, short-range communication such as NearField Communication (NFC), having a theoretical working distance of 20centimeters and a practical working distance of about 4 centimeters, andcommonly used with mobile devices, such as smartphones. The NFCtypically operates at 13.56 MHz as defined in IS O/IEC 18000-3 airinterface, and at data rates ranging from 106 kbit/s to 424 kbit/s. NFCcommonly involves an initiator and a target; the initiator activelygenerates an RF field that may power a passive target. NFC peer-to-peercommunication is possible, provided both devices are powered.

The NFC typically supports passive and active modes of operation. Inpassive communication mode, the initiator device provides a carrierfield and the target device answers by modulating the existing field,and the target device may draw its operating power from theinitiator-provided electromagnetic field, thus making the target devicea transponder. In active communication mode, both devices typically havepower supplies, and both initiator and target devices communicate byalternately generating their own fields, where a device deactivates itsRF field while it is waiting for data. NFC typically usesAmplitude-Shift Keying (ASK), and employs two different schemes totransfer data. At the data transfer rate of 106 kbit/s, a modifiedMiller coding with 100% modulation is used, while in all other casesManchester coding is used with a modulation ratio of 10%.

The NFC communication may be partly or in full in accordance with, orbased on, NFC standards ISO/IEC 18092 or ECMA-340 entitled: “Near FieldCommunication Interface and Protocol-1 (NFCIP-1)”, and ISO/IEC 21481 orECMA-352 standards entitled: “Near Field Communication Interface andProtocol-2 (NFCIP-2)”. The NFC technology is described in ECMAInternational white paper Ecma/TC32-TG19/2005/012 entitled: “Near FieldCommunication—White paper”, in Rohde&Schwarz White Paper 1MA182_4eentitled: “Near Field Communication (NFC) Technology and MeasurementsWhite Paper”, and in Jan Kremer Consulting Services (JKCS) white paperentitled: “NFC—Near Field Communication—White paper”, which are allincorporated in their entirety for all purposes as if fully set forthherein.

Random. Randomness is commonly implemented by using random numbers,defined as a sequence of numbers or symbols that lack any pattern andthus appear random, are often generated by a random number generator.Randomness for security is also described in IETF RFC 1750 “RandomnessRecommendations for Security” (December 1994), which is incorporated inits entirety for all purposes as if fully set forth herein. A randomnumber generator (having either analog or digital output) can behardware based, using a physical process such as thermal noise, shotnoise, nuclear decaying radiation, photoelectric effect or other quantumphenomena. Alternatively, or in addition, the generation of the randomnumbers can be software based, using a processor executing an algorithmfor generating pseudo-random numbers which approximates the propertiesof random numbers.

The term ‘random’ herein is intended to cover not only pure random,non-deterministically and non-predicted generated signals, but alsopseudo-random, deterministic signals such as the output of ashift-register arrangement provided with a feedback circuit as used togenerate pseudo-random binary signals or as scramblers, and chaoticsignals, and where a randomness factor may be used.

A digital random signal generator (known as random number generator)wherein numbers in binary form replaces the analog voltage value outputmay be used for any randomness. One approach to random number generationis based on using linear feedback shift registers. An example of randomnumber generators is disclosed in U.S. Pat. No. 7,124,157 to Ikakeentitled: “Random Number Generator”, in U.S. Pat. No. 4,905,176 toSchulz entitled: “Random Number Generator Circuit”, in U.S. Pat. No.4,853,884 to Brown et al. entitled: “Random Number Generator withDigital Feedback” and in U.S. Pat. No. 7,145,933 to Szajnowski entitled:“Method and Apparatus for generating Random signals”, which areincorporated in its entirety for all purposes as if fully set forthherein.

A digital random signal generator may be based on ‘True Random NumberGeneration IC RPG100/RPG100B’ available from FDK Corporation anddescribed in the data sheet ‘Physical Random number generatorRPG100.RPG100B’ REV. 08 publication number HM-RAE106-0812, which isincorporated in its entirety for all purposes as if fully set forthherein. The digital random signal generator can be hardware based,generating random numbers from a natural physical process or phenomenon,such as the thermal noise of semiconductor which has no periodicity.Typically, such hardware random number generators are based onmicroscopic phenomena such as thermal noise, shot noise, nucleardecaying radiation, photoelectric effect or other quantum phenomena, andtypically contain a transducer to convert some aspect of the physicalphenomenon to an electrical signal, an amplifier and other electronic tobring the output into a signal that can be converted into a digitalrepresentation by an analog to digital converter. In the case wheredigitized serial random number signals are generated, the output isconverted to parallel, such as 8 bits data, with 256 values of randomnumbers (values from 0 to 255). Alternatively, a digital random signalgenerator may be software (or firmware) based, such as pseudo-randomnumber generators. Such generators include a processor for executingsoftware that includes an algorithm for generating numbers, whichapproximates the properties of random numbers. The random signalgenerator (either analog or digital) may output a signal having uniformdistribution, in which there is a substantially or purely equalprobability of a signal falling between two defined limits, having noappearance outside these limits. However, Gaussian and otherdistribution may be equally used.

Electronic circuits and components are described in a book by Wikipediaentitled: “Electronics” downloaded from en.wikibooks.org dated Mar. 15,2015, which is incorporated in its entirety for all purposes as if fullyset forth herein.

Smartphone. A mobile phone (also known as a cellular phone, cell phone,smartphone, or hand phone) is a device which can make and receivetelephone calls over a radio link whilst moving around a wide geographicarea, by connecting to a cellular network provided by a mobile networkoperator. The calls are to and from the public telephone network, whichincludes other mobiles and fixed-line phones across the world. TheSmartphones are typically hand-held and may combine the functions of apersonal digital assistant (PDA), and may serve as portable mediaplayers and camera phones with high-resolution touch-screens, webbrowsers that can access, and properly display, standard web pagesrather than just mobile-optimized sites, GPS navigation, Wi-Fi andmobile broadband access. In addition to telephony, the Smartphones maysupport a wide variety of other services such as text messaging, MMS,email, Internet access, short-range wireless communications (infrared,Bluetooth), business applications, gaming and photography.

An example of a contemporary smartphone is model iPhone 6 available fromApple Inc., headquartered in Cupertino, Calif., U.S.A. and described iniPhone 6 technical specification (retrieved October 2015 fromwww.apple.com/iphone-6/specs/), and in a User Guide dated 2015(019-00155/2015-06) by Apple Inc. entitled: “iPhone User Guide For iOS8.4 Software”, which are both incorporated in their entirety for allpurposes as if fully set forth herein. Another example of a smartphoneis Samsung Galaxy S6 available from Samsung Electronics headquartered inSuwon, South-Korea, described in the user manual numbered English (EU),March 2015 (Rev. 1.0) entitled: “SM-G925F SM-G925FQ SM-G9251 UserManual” and having features and specification described in “Galaxy S6Edge—Technical Specification” (retrieved October 2015 fromwww.samsung.com/us/explore/galaxy-s-6-features-and-specs), which areboth incorporated in their entirety for all purposes as if fully setforth herein.

Instant Messaging. Instant Messaging (IM) is a type of online chat,which offers real-time text transmission over the Internet. Shortmessages are typically transmitted bi-directionally between two parties,when each user chooses to complete a thought and select “send”. Some IMapplications can use push technology to provide real-time text, whichtransmits messages character by character, as they are composed. Moreadvanced instant messaging can add file transfer, clickable hyperlinks,Voice over IP, or video chat. Instant messaging systems typicallyfacilitate connections between specified known users (often using acontact list also known as a “buddy list” or “friend list”). Dependingon the IM protocol, the technical architecture can be peer-to-peer(direct point-to-point transmission) or client-server (a central serverretransmits messages from the sender to the communication device).

Instant messaging is a set of communication technologies used fortext-based communication between two or more participants over theInternet or other types of networks. IM-chat happens in real-time. Ofimportance is that online chat and instant messaging differ from othertechnologies such as email due to the perceived quasi-synchrony of thecommunications by the users. Some systems permit messages to be sent tousers not then ‘logged on’ (offline messages), thus removing somedifferences between IM and email (often done by sending the message tothe associated email account). Various IP technologies are described ina thesis by Tim van Lokven (Jan. 23, 2011) entitled: “Review andComparison of Instant Messaging Protocols”, which is incorporated in itsentirety for all purposes as if fully set forth herein.

Text Messaging. Text messaging, or texting, is the act of composing andsending brief, electronic messages between two or more mobile phones, orfixed or portable devices over a phone network. The term commonly refersto messages sent using the Short Message Service (SMS), but may includemessages containing image, video, and sound content (known as MMSmessages). The sender of a text message is known as a texter, while theservice itself has different colloquialisms depending on the region.Text messages can be used to interact with automated systems, forexample, to order products or services, or to participate in contests.Advertisers and service providers use direct text marketing to messagemobile phone users about promotions, payment due dates, et ceterainstead of using mail, e-mail or voicemail. In a straight and concisedefinition for the purposes of this English language article, textmessaging by phones or mobile phones should include all 26 letters ofthe alphabet and 10 numerals, i.e., alpha-numeric messages, or text, tobe sent by texter or received by the textee. SMS messaging gatewayproviders can provide gateway-to-mobile (Mobile Terminated—MT) services.Some suppliers can also supply mobile-to-gateway (text-in or MobileOriginated/MO services).

SMS. Short Message Service (SMS) is a text messaging service componentof phone, Web, or mobile communication systems. It uses standardizedcommunications protocols to allow fixed line or mobile phone devices toexchange short text messages. SMS as used on modern handsets as part ofthe Global System for Mobile Communications (GSM) series of standards asa means of sending messages of up to 160 characters to and from GSMmobile handsets. Though most SMS messages are mobile-to-mobile textmessages, support for the service has expanded to include other mobiletechnologies, such as ANSI CDMA networks and Digital AMPS, as well assatellite and landline networks. The Short Message Service-Point toPoint (SMS-PP) is standardized by the 3GPP as TS 23.040 and 3GPP TS23.041, which define the Short Message Service-Cell Broadcast (SMS-CB),which allows messages (advertising, public information, etc.) to bebroadcast to all mobile users in a specified geographical area.

Messages are sent to a Short Message Service Center (SMSC), whichprovides a “store and forward” mechanism. It attempts to send messagesto the SMSC recipients, and if a recipient is not reachable, the SMSCqueues the message for later retry. Some SMSCs also provide a “forwardand forget” option where transmission is tried only once. Both MobileTerminated (MT, for messages sent to a mobile handset) and MobileOriginating (MO, for those sent from the mobile handset) operations aresupported, and the message delivery is “best effort” scheme, so thereare no guarantees that a message will actually be delivered to itsrecipient, but delay or complete loss of a message is uncommon. SMS is astateless communication protocol in which every SMS message isconsidered entirely independent of other messages. Enterpriseapplications using SMS as a communication channel for stateful dialogue(where an MO reply message is paired to a specific MT message) requiresthat session management be maintained external to the protocol throughproprietary methods as Dynamic Dialogue Matrix (DDM).

The Short Message Service is realized by the use of the MobileApplication Part (MAP) of the SS#7 protocol, with Short Message protocolelements being transported across the network as fields within the MAPmessages. These MAP messages may be transported using ‘traditional’ TDMbased signaling, or over IP using SIGTRAN and an appropriate adaptationlayer. The Short Message protocol itself is defined by 3GPP TS 23.040for the Short Message Service-Point-to-Point (SMS-PP), and 3GPP TS23.041 for the Cell Broadcast Service (CBS). SMS is further described ina 3GPP Technical Specification 3GPP TS 22.011 (v143.0.0, 2015 September)entitled: “3rd Generation Partnership Project; Technical SpecificationGroup Services and System Aspects; Service accessibility (Release 14)”,which is incorporated in its entirety for all purposes as if fully setforth herein.

MMS. Multimedia Messaging Service (MMS) is an Open Mobile Alliance (OMA)standard way to send messages that include multimedia content to andfrom mobile phones over a cellular network. It extends the core SMS(Short Message Service) capability that allowed exchange of textmessages only up to 160 characters in length. The most popular use is tosend photographs from camera-equipped handsets, and is used on acommercial basis by media companies as a method of delivering news andentertainment content and by retail brands as a tool for deliveringscannable coupon codes, product images, videos and other information.Unlike text only SMS, commercial MMS can deliver a variety of mediaincluding up to forty seconds of video, one image, multiple images viaslideshow, or audio plus unlimited characters.

MMS messages are delivered differently from SMS. The first step is forthe sending device to encode the multimedia content in a fashion similarto sending a MIME e-mail (MIME content formats are defined in the MMSMessage Encapsulation specification). The message is then forwarded tothe carrier MMS store and forward server, known as the MMSC (MultimediaMessaging Service Centre). If the receiver is on another carrier, thenthe MMSC acts as a relay, and forwards the message to the MMSC of therecipient's carrier using the Internet.

Once the recipient MMSC has received a message, it first determineswhether the receiver's handset is “MMS capable”, that it supports thestandards for receiving MMS. If so, the content is extracted and sent toa temporary storage server with an HTTP front-end. An SMS “controlmessage”(ping) containing the URL of the content is then sent to therecipient's handset to trigger the receiver's WAP browser to open andreceive the content from the embedded URL. Several other messages areexchanged to indicate status of the delivery attempt. Before deliveringcontent, some MMSCs also include a conversion service known as “contentadaptation” that will attempt to modify the multimedia content into aformat suitable for the receiver. E-mail and web-based gateways to theMMS (and SMS) system are common. On the reception side, the contentservers can typically receive service requests from both WAPs and normalHTTP browsers, so delivery via the web is simple. For sending fromexternal sources to handsets, most carriers allow MIME encoded messageto be sent to the receiver's phone number with a special domain. MMS isdescribed in a 3GPP technical specification 3GPP TS 23.140 V6.16.0 (2009March) entitled: “3rd Generation Partnership Project; TechnicalSpecification Group Core Network and Terminals; Multimedia MessagingService (MMS); Functional description; Stage 2 (Release 6)”, which isincorporated in its entirety for all purposes as if fully set forthherein.

Facebook. Facebook Messenger is an instant messaging service andsoftware application which provides text and voice communication.Integrated with Facebook web-based Chat feature and built on the openMQTT protocol, Messenger lets Facebook users chat with friends both onmobile and on the main website. Facebook is described in a guide byAmerican Majority organization (retrieved October 2015 fromhttp://cmrw.org/) entitled: “facebook—A Beginner's Guide”, which isincorporated in its entirety for all purposes as if fully set forthherein.

Twitter. Twitter is an online social networking service by Twitter Inc.(headquartered in San Francisco) that enables users to send and readshort 140-character messages called “tweets”. Registered users can readand post tweets, but unregistered users can only read them. Users accessTwitter through the website interface, SMS, or mobile deviceapplications. Tweets are publicly visible by default, but senders canrestrict message delivery to just their followers. Users can tweet viathe Twitter website, compatible external applications (such as forsmartphones), or by Short Message Service (SMS) available in certaincountries. The action of forwarding a tweet via Twitter is referred toas Retweeting. Both tweets and retweets can be tracked to see which onesare most popular. Users may subscribe to other users tweets—this isknown as “following” and subscribers are known as “followers” or“tweeps”, a portmanteau of Twitter and peeps. Users can check the peoplewho are unsubscribing them on Twitter (“unfollowing”) via variousservices. In addition, users can block those who have followed them. Asa social network, Twitter revolves around the principle of followers.When you choose to follow another Twitter user that user's tweets appearin reverse chronological order on your main Twitter page. Individualtweets are registered under unique IDs using software called snowflake,and geolocation data is added using ‘Rockdove’. The URL t.co then checksfor a spam link and shortens the URL. Next, the tweets are stored in aMySQL database using Gizzard, and the user receives acknowledgement thatthe tweets were sent. Tweets are then sent to search engines via theFirehose API. The process itself is managed by FlockDB and takes anaverage of 350 ms, and the service's Application Programming Interface(API) allows other web services and applications to integrate withTwitter. Twitter is described in a guide (retrieved October 15 fromhttps://g.twimg.com/business/pdfs/Twitter_Smallbiz_Guide.pdf) byTwitter, Inc., entitled: “Twitter for Small Business—A GUIDE TO GETSTARTED”, which is incorporated in its entirety for all purposes as iffully set forth herein.

WhatsApp. WhatsApp is an instant messaging app developed by WhatsAppInc. (headquartered in Mountain View, Calif.) for smartphones thatoperates under a subscription business model. The proprietary,cross-platform app uses the Internet to send text messages, images,video, user location, and audio media messages. WhatsApp uses acustomized version of the open standard Extensible Messaging andPresence Protocol (XMPP). Upon installation, it creates a user accountusing one's phone number as the username (Jabber ID: [phone number]@s.whatsapp.net) WhatsApp software automatically compares all the phonenumbers from the device's address book with its central database ofWhatsApp users to automatically add contacts to the user's WhatsAppcontact list.

Multimedia messages are sent by uploading the image, audio or video tobe sent to an HTTP server and then sending a link to the content alongwith its Base64 encoded thumbnail (if applicable). WhatsApp follows a‘store and forward’ mechanism for exchanging messages between two users.When a user sends a message, it first travels to the WhatsApp serverwhere it is stored. Then the server repeatedly requests the receiveracknowledge receipt of the message. As soon as the message isacknowledged, the server drops the message; it is no longer available indatabase of server. The WhatsApp service is described in an articlepublished (Aug. 30, 2013) on MOBILE HCI 2013—COLLABORATION ANDCOMMUNICATION by Karen Church and Rodrigo de Oliveira (both ofTelefonica Research) entitled: “What's up with WhatsApp? ComparingMobile Instant-Messaging Behaviors with Traditional SMS”, which isincorporated in its entirety for all purposes as if fully set forthherein.

Viber. Viber is an instant messaging and Voice over IP (VoIP) app forsmartphones developed by Viber Media, where in addition to instantmessaging, users can exchange images, video and audio media messages.Viber works on both 3G/4G and Wi-Fi networks. Viber includes text,picture and video messaging across all platforms, with voice callingavailable only to iPhone, Android and Microsoft's Windows Phone. Theapplication user interface includes tab bar on the bottom, giving accessto messages, recent calls, contact, the keypad and a button foraccessing more options. Upon installation, it creates a user accountusing one's phone number as username. Viber synchronizes with thephone's address book, so users do not need to add contacts in a separatebook. Since all users are registered with their phone number, thesoftware returns all Viber users among the user contacts.

Mail Server. Mail server (a.k.a. Email server, Electronic Mail server,Mail Exchanger—MX) refer to a server operating as an electronic postoffice for email exchanging across networks, commonly performing theserver-side of an MTA function. A Message Transfer Agent (or MailTransfer Agent—MTA), or mail relay is a software that transferselectronic mail messages from one computer to another using aclient-server application architecture. An MTA typically implements boththe client (sending) and server (receiving) portions of the Simple MailTransfer Protocol (SMTP). The Internet mail architecture is described inIETF RFC 5598 entitled: “Internet Mail Architecture”, and the SMTPprotocol is described in IETF RFC 5321 entitled: “Simple Mail TransferProtocol” and in IETF RFC 7504 entitled: “SMTP 521 and 556 Reply Codes”,which are all incorporated in their entirety for all purposes as iffully set forth herein.

The Domain Name System (DNS) typically associates a mail server to adomain with mail exchanger (MX) resource records, containing the domainname of a host providing MTA services. A message transfer agent receivesmail from either another MTA, a Mail Submission Agent (MSA), or a MailUser Agent (MUA). The transmission details are specified by the SimpleMail Transfer Protocol (SMTP). When a recipient mailbox of a message isnot hosted locally, the message is relayed, that is, forwarded toanother MTA. Every time an MTA receives an email message, it adds a‘Received’ trace header field to the top of the header of the message,thereby building a sequential record of MTAs handling the message. Theprocess of choosing a target MTA for the next hop is also described inSMTP, but can usually be overridden by configuring the MTA software withspecific routes. Internet mail schemes are described in IEEE Annals ofthe History of Computing paper published 2008 by the IEEE ComputerSociety [1058-6180/08], authored by Craig Partridge of BBN Technologiesentitled: “The technical Development of Internet Mail”, which isincorporated in its entirety for all purposes as if fully set forthherein.

A mail server infrastructure consists of several components that worktogether to send, relay, receive, store, and deliver email, andtypically uses various Internet standard protocols for sending andretrieving email, such as the Internet standard protocol Simple MailTransfer Protocol (SMTP) for sending email, the Internet standardprotocols for retrieving email Post Office Protocol (POP), and InternetMessage Access Protocol version 4 (IMAPv4). An example of a mail serversoftware is ‘Microsoft Exchange Server 2013’ (available from MicrosoftCorporation, headquartered in Redmond, Wash., U.S.A.), described in‘Pocket Consultant’ book [ISBN: 978-0-7356-8168-2] published 2013 byMicrosoft Press and entitled: “Microsoft Exchange Server2013—Configuration & Clients”, which is incorporated in its entirety forall purposes as if fully set forth herein.

The POP is specified in IETF RFC 1939 entitled: “Post Office Protocol”,and updated specification with an extension mechanism is described inIETF RFC 2449 entitled: “POP3 Extension Mechanism”, and anauthentication mechanism is described in IETF RFC 1734 entitled: “POP3AUTHentication command”, which are all incorporated in their entiretyfor all purposes as if fully set forth herein. IMAP4 clients can create,rename, and/or delete mailboxes (usually presented to the user asfolders) on the mail server, and copy messages between mailboxes, andthis multiple mailbox support also allows servers to access shared andpublic folders. IMAP4 is described in IETF RFC 3501 entitled: “INTERNETMESSAGE ACCESS PROTOCOL—VERSION 4rev1”, and the IMAP4 Access ControlList (ACL) Extension may be used to regulate access rights, and isdescribed in IETF RFC 4314 entitled: “IMAP4 Access Control List (ACL)Extension”, which are both incorporated in their entirety for allpurposes as if fully set forth herein.

Mail servers may be operated, or used by mailbox providers, and mailservers are described in U.S. Pat. No. 5,832,218 to Gibbs et al.entitled: “Client/server Electronic Mail System for Providing Off-LineClient Utilization and Seamless Server Resynchronization”, in U.S. Pat.No. 6,081,832 to Gilchrist et al. entitled: “Object Oriented Mail ServerFramework Mechanism”, in U.S. Pat. No. 7,136,901 to Chung et al.entitled: “Electronic Mail Server”, and in U.S. Pat. No. 7,818,383 toKodama entitled: “E-Mail Server”, which are all incorporated in theirentirety for all purposes as if fully set forth herein.

XMPP. Extensible Messaging and Presence Protocol (XMPP) is an openstandard communications protocol for message-oriented middleware basedon XML (Extensible Markup Language) that enables the near-real-timeexchange of structured yet extensible data between any two or morenetwork entities. Designed to be extensible, the protocol has also beenused for publish-subscribe systems, signaling for VoIP, video, filetransfer, gaming, Internet of Things (IoT) applications such as thesmart grid, and social networking services. The XMPP network uses aclient-server architecture where clients do not talk directly to oneanother. The model is decentralized and anyone can run a server. Bydesign, there is no central authoritative. Every user on the network hasa unique XMPP address, called JID (for historical reasons, XMPPaddresses are often called Jabber IDs). The JID is structured like anemail address with a username and a domain name (or IP address) for theserver where that user resides, separated by an at sign (@), such asusername@example.com. Since a user may wish to log in from multiplelocations, they may specify a resource. A resource identifies aparticular client belonging to the user (for example home, work, ormobile). This may be included in the JID by appending a slash followedby the name of the resource. For example, the full JID of a user'smobile account could be username@example.com/mobile. Each resource mayhave specified a numerical value called priority. Messages simply sentto username@example.com will go to the client with highest priority, butthose sent to username@example.com/mobile will go only to the mobileclient. The highest priority is the one with largest numerical value.JIDs without a username part are also valid, and may be used for systemmessages and control of special features on the server. A resourceremains optional for these JIDs as well. XMPP is described in IETF RFC6120 entitled: “Extensible Messaging and Presence Protocol (XMPP):Core”, which describes client-server messaging using two open-ended XMLstreams, in IETF RFC 6121 entitled: “Extensible Messaging and PresenceProtocol (XMPP): Instant Messaging and Presence”, which describesinstant messaging (IM), the most common application of XMPP, and in IETFRFC 6122 entitled: “Extensible Messaging and Presence Protocol (XMPP):Address Format”, which describes the rules for XMPP addresses, alsocalled JabberIDs or JIDs.

SIMPLE. The Session Initiation Protocol (SIP) for Instant Messaging andPresence Leveraging Extensions (SIMPLE) is an open standard InstantMessaging (IM) and presence protocol suite based on Session InitiationProtocol (SIP) managed by the Internet Engineering Task Force. TheSIMPLE presence use the core protocol machinery that provides the actualSIP extensions for subscriptions, notifications and publications. IETFRFC 6665 defines the SUBSCRIBE and NOTIFY methods, where SUBSCRIBEallows to subscribe to an event on a server, and the server respondswith NOTIFY whenever the event come up. IETF RFC 3856 defines how tomake use of SUBSCRIBE/NOTIFY for presence. Two models are defined: anend-to-end model in which each User Agent handles presence subscriptionsitself, and a centralized model. The message PUBLISH (IETF RFC 3903)allows User Agents to inform the presence server about theirsubscription states.

SIP defines two modes of instant messaging: The Page Mode makes use ofthe SIP method MESSAGE, as defined in IETF RFC 3428. This modeestablishes no sessions, and the Session Mode. The Message Session RelayProtocol (RFC 4975, RFC 4976) is a text-based protocol for exchangingarbitrarily-sized content between users, at any time. An MSRP session isset up by exchanging certain information, such as an MSRP URI, withinSIP and SDP signaling. SIMPLE is described in IETF RFC 6914 entitled:“SIMPLE Made Simple: An Overview of the IETF Specifications for InstantMessaging and Presence Using the Session Initiation Protocol (SIP)”,which is incorporated in its entirety for all purposes as if fully setforth herein.

Wearables. As used herein, the term “wearable device” (or “wearable”)includes a body-borne device (or item) designed or intended to be wornby a human. Such devices are typically comfortably worn on, and arecarried or transported by, the human body, and are commonly used tocreate constant, convenient, seamless, portable, and mostly hands-freeaccess to electronics and computers. The wearable devices may be indirect contact with the human body (such as by touching, or attachingto, the body skin), or may be releasably attachable to clothes or otheritems intended or designed to be worn on the human body. In general, thegoal of wearable technologies is to smoothly incorporate functional,portable electronics and computers into individuals' daily lives.Wearable devices may be releasably attached to the human body usingattaching means such as straps, buckles, belts, or clasps. Alternativelyor in addition, wearable devices may be shaped, structured, or having aform factor to be body releasably mountable or attachable, such as usingeye-glass frames or headphones. Further, wearable devices may be wornunder, with, or on top of, clothing.

Wearable devices may interact as sensors or actuators with an organ orpart of the human body, such as a head mounted wearable device mayinclude a screen suspended in front of a user's eye, without providingany aid to the user's vision. Examples of wearable devices includewatches, glasses, contact lenses, pedometers, chest straps, wrist-bands,head bands, arm bands, belt, head wear, hats, glasses, watches,sneakers, clothing, pads, e-textiles and smart fabrics, headbands,beanies, and caps, as well as jewelry such as rings, bracelets, andhearing aid-like devices that are designed to look like earrings. Awearable device may be structured, designed, or have a form factor thatis identical to, substantially similar to, or is at least in partsubstitute to, a traditional wearable item.

A wearable device may be a headwear that may be structured, designed, orhave a form factor that is identical to, substantially similar to, or isat least in part substitute to, any headwear item. The headwear may beattached to, or be in contact with, a head part, such as a face, nose,right nostril, left nostril, right cheek, left cheek, right eye, lefteye, right ear, or left ear, nose, mouth, lip, forehead, or chin. Awearable device may be structured, designed, or have a form factor thatis identical to, substantially similar to, or is at least in partsubstitute to, a bonnet, a cap, a crown, a fillet, a hair cover, a hat,a helmet, a hood, a mask, a turban, a veil, or a wig.

A headwear device may be an eyewear that may be structured, designed, orhave a form factor that is identical to, substantially similar to, or isat least in part substitute to, any eyewear item, such as glasses,sunglasses, a contact lens, a blindfold, or a goggle. A headwear devicemay be an earpiece that may be structured, designed, or have a formfactor that is identical to, substantially similar to, or is at least inpart substitute to, any earpiece item, such as a hearing aid, aheadphone, a headset, or an earplug.

A wearable device may be releasably or permanently attach to, or be partof, a clothing article such as a tie, sweater, jacket, or hat. Theattachment may use taping, gluing, pinning, enclosing, encapsulating, orany other method of attachment or integration known in the art.Furthermore, in some embodiments, there may be an attachment elementsuch as a pin or a latch and hook system, of portion thereof (with thecomplementary element on the item to which it is to be affixed) or clip.In a non-limiting example, the attachment element has a clip-like designto allow attachment to pockets, belts, watches, bracelets, broaches,rings, shoes, hats, bike handles, necklaces, ties, spectacles, collars,socks, bags, purses, wallets, or cords.

A wearable device may be releasably or permanently attach to, or be partof, a top underwear such as a bra, camisole, or undershirt, a bottomunderwear such as a diaper, panties, plastic pants, slip, thong,underpants, boxer briefs, boxer shorts, or briefs, or a full-bodyunderwear such as bodysuit, long underwear, playsuit, or teddy.Similarly, a wearable device may be releasably or permanently attach to,or be part of, a headwear such as a Baseball cap, Beret, Cap, Fedora,hat, helmet, hood, knit cap, toque, turban, or veil. Similarly, awearable device may be releasably or permanently attach to, or be partof, a footwear such as an athletic shoe, boot, court shoe, dress shoe,flip-flops, hosiery, sandal, shoe, spats, slipper, sock, or stocking.Further, a wearable device may be releasably or permanently attach to,or be part of, an accessory such as a bandana, belt, bow tie, coinpurse, cufflink, cummerbund, gaiters, glasses, gloves, headband,handbag, handkerchief, jewellery, muff, necktie, pocket protector,pocketwatch, sash, scarf, sunglasses, suspenders, umbrella, wallet, orwristwatch.

A wearable device may be releasably or permanently attach to, or be partof, an outwear such as an apron, blazer, British warm, cagoule, cape,chesterfield, coat, covert coat, cut-off, duffle coat, flight jacket,gilet, goggle jacket, guards coat, Harrington jacket, hoodie, jacket,leather jacket, mess jacket, opera coat, overcoat, parka, paletot, peacoat, poncho, raincoat, robe, safari jacket, shawl, shrug, ski suit,sleeved blanket, smoking jacket, sport coat, trench coat, ulster coat,waistcoat, or windbreaker. Similarly, a wearable device may bereleasably or permanently attach to, or be part of, a suit (or uniform)such as an academic dress, ball dress, black tie, boilersuit, cleanroomsuit, clerical clothing, court dress, gymslip, jumpsuit, kasaya, labcoat, military uniform, morning dress, onesie, pantsuit, red sea rig,romper suit, school uniform, scrubs, stroller, tuxedo, or white tie.Further, a wearable device may be releasably or permanently attach to,or be part of, a dress such as a ball gown, bouffant gown, coatdress,cocktail dress, debutante dress, formal wear, frock, evening gown, gown,house dress, jumper, little black dress, princess line, sheath dress,shirtdress, slip dress, strapless dress, sundress, wedding dress, orwrap dress. Furthermore, a wearable device may be releasably orpermanently attach to, or be part of, a skirt such as an A-line skirt,ballerina skirt, denim skirt, men's skirts, miniskirt, pencil skirt,prairie skirt, rah-rah skirt, sarong, Skort, tutu, or wrap. In oneexample, a wearable device may be releasably or permanently attach to,or be part of, a trousers (or shorts) such as bell-bottoms, bermudashorts, bondage pants, capri pants, cargo pants, chaps, cycling shorts,dress pants, high water pants, lowrise pants, Jeans, jodhpurs, leggings,overall, Palazzo pants, parachute pants, pedal pushers, phat pants,shorts, slim-fit pants, sweatpants, windpants, or yoga pants. In oneexample, a wearable device may be releasably or permanently attach to,or be part of, a top such as a blouse, crop top, dress shirt, guayabera,guernsey, halterneck, henley shirt, hoodie, jersey, polo shirt, shirt,sleeveless shirt, sweater, sweater vest, t-shirt, tube top, turtleneck,or twinset.

A wearable device may be structured, designed, or have a form factorthat is identical to, substantially similar to, or is at least in partsubstitute to, a fashion accessory. These accessories may be purelydecorative, or have a utility beyond aesthetics. Examples of theseaccessories include, but are not limited to, rings, bracelets,necklaces, watches, watch bands, purses, wallets, earrings, body rings,headbands, glasses, belts, ties, tie bars, tie tacks, wallets, shoes,pendants, charms and bobbles. For example, wearable devices may also beincorporated into pockets, steering wheels, keyboards, pens, and bicyclehandles.

In one example, the wearable device may be shaped as, or integratedwith, a device that includes an annular member defining an aperturetherethrough that is sized for receipt therein of a human body part. Thebody part may be part of a human hand such as upper arm, elbow, forearm,wrist (such as a wrist-band), or a finger (such as a ring).Alternatively or in addition, the body part may be part of a human heador neck, such as a forehead, ear, skull, or face. Alternatively or inaddition, the body part may be part of a human thorax or abdomen, suchas waist or hip. Alternatively or in addition, the body part may be partof a human leg or foot, such as thigh, calf, ankle, instep, knee, ortoe.

In one example, the wearable device may be shaped as, or integratedwith, a ring. The ring may comprise, consist essentially of or consistof a shank, which is the location that provides an opening for a finger,and a head, which comprises, consists essentially or consists ofornamental features of the ring and in some embodiments houses thesignaling assembly of the present device. The head may be of any shape,e.g., a regular sphere, truncated sphere, cube, rectangular prism,cylinder, triangular prism, cone, pyramid, barrel, truncated cone, domedcylinder, truncated cylinder, ellipsoid, regular polygon prism ortruncated three-dimensional polygon of e.g., 4-16 sides, such as atruncated pyramid (trapezoid), or combination thereof or it may be anirregular shape. Further, the head may comprise an upper face thatcontains and is configured to show one or more jewels and/or ornamentaldesigns.

A mobile communication device configured to be worn on an index fingerof a user's hand is described in U.S. Patent Application Publication No.2015/0373443 to Carroll entitled: “Finger-wearable mobile communicationdevice”, which is incorporated in its entirety for all purposes as iffully set forth herein. The device includes a case, a microphone, aswitch, and a power source. The microphone and the switch arestrategically located along a shape of the case so that as worn on theuser's index finger and when the switch is activated by the thumb of theuser's hand, the hand naturally cups about the microphone to form abarrier to ambient noise. Further, the microphone can readily be locatednear a corner of the user's mouth for optimal speech-receivingconditions and to provide more private audio input.

A user controls an external electronic device with a finger-ring-mountedtouchscreen is described in U.S. Patent Application Publication No.2015/0277559 to Vescovi et al. entitled: “Devices and Methods for a RingComputing Device”, which is incorporated in its entirety for allpurposes as if fully set forth herein. The device includes a computerprocessor, wireless transceiver, and rechargeable power source; the ringis worn on a first finger receives an input from a second finger,selects one of a plurality of touch events associated with the input,and wirelessly transmits a command associated with the touch event tothe external electronic device.

A mobile communication device that comprises a fashion accessory and asignaling assembly is described in U.S. Patent Application PublicationNo. 2015/0349556 to Mercando et al. entitled: “Mobile CommunicationDevices”, which is incorporated in its entirety for all purposes as iffully set forth herein. The signaling assembly may be configured toprovide sensory stimuli such as a flashing LED light and a vibration.These stimuli may vary depending on the signal received from a remotecommunication device or from gestures made by a user or from informationstored in the mobile communication device.

A wearable fitness-monitoring device is described in U.S. Pat. No.8,948,832 to Hong et al. entitled: “Wearable Heart Rate Monitor”, whichis incorporated in its entirety for all purposes as if fully set forthherein. The device includes a motion sensor and a photoplethysmographic(PPG) sensor. The PPG sensor includes (i) a periodic light source, (ii)a photo detector, and (iii) circuitry determining a user's heart ratefrom an output of the photo detector. Some embodiments provide methodsfor operating a heart rate monitor of a wearable fitness-monitoringdevice to measure one or more characteristics of a heartbeat waveform.Some embodiments provide methods for operating the wearable fitnessmonitoring device in a low power state when the device determines thatthe device is not worn by a user. Some embodiments provide methods foroperating the wearable fitness-monitoring device in a normal power statewhen the device determines that the device is worn by a user.

A wearable device and method for processing mages to prolong batterylife are described in U.S. Pat. No. 8,957,988 to Wexler et al. entitled:“Apparatus for processing images to prolong battery life”, which isincorporated in its entirety for all purposes as if fully set forthherein. In one implementation, a wearable apparatus may include awearable image sensor configured to capture a plurality of images froman environment of a user. The wearable apparatus may also include atleast one processing device configured to, in a first processing-mode,process representations of the plurality of images to determine a valueof at least one capturing parameter for use in capturing at least onesubsequent image, and in a second processing-mode, process therepresentations of the plurality of images to extract information. Inaddition, the at least one processing device may operate in the firstprocessing-mode when the wearable apparatus is powered by a mobile powersource included in the wearable apparatus and may operate in the secondprocessing-mode when the wearable apparatus is powered by an externalpower source.

A wearable device may be used for notifying a person, such as by usingtactile, visual, or audible stimulus, as described for example in U.S.Patent Application No. 2015/0341901 to RYU et al. entitled: “Method andapparatus for providing notification”, which is incorporated in itsentirety for all purposes as if fully set forth herein, describing anelectronic device that includes: a transceiver configured to communicatewith at least one wearable device and receive, from the at least onewearable device, status information indicating whether the at least onewearable device is currently being worn; and a processor configured todetermine whether to send a notification request to the at least onewearable device based on the status information received by thetransceiver.

A communication device, system and method are described for example inU.S. Patent Application No. 2007/0052672 to Ritter et al. entitled:“Communication device, system and method”, which is incorporated in itsentirety for all purposes as if fully set forth herein. It is disclosescomprising a Virtual Retinal Display (VRD) in form of glasses (1), atleast one haptic sensor (12) mounted on the frame of said glasses orconnected by a short range communication interface (13) to said glasses(1), wherein it is possible to navigate by means of a cursor through animage displayed by the Virtual Retinal Display (VRD) with the at leastone haptic sensor (12). A central control unit controls (11) the VirtualRetinal Display (VRD) and the at least one haptic sensor (12). When theVirtual Retinal Display (VRD) is connected to an external device (2, 9)by a short range communication interface (13), the user can navigatethrough the content of the external device (2, 9) by easy use of thehaptic sensor (12).

Wearable communication devices, e.g. implemented in a watch, using shortrange communication to a cell phone, and facilitating natural andintuitive user interface with low-power implementation are described forexample in U.S. Patent Application No. 2014/0045547 to Singamsetty etal. entitled: “Wearable Communication Device and User Interface”, whichis incorporated in its entirety for all purposes as if fully set forthherein. The devices allow a user to easily access all features of thephone, all while a phone is nearby but not visible. Notification isperformed with vibration, an LED light and OLED text display of incomingcalls, texts, and calendar events. It allows communicating hands-free.This allows using the communication device as “remote control” for homedevices, etc. via voice and buttons. The device comprises interfacesmotion sensors such as accelerometers, magnetometer and gyroscope,infrared proximity sensors, vibrator motor, and/or voice recognition.Low power consumption is achieved by dynamical configuration of sensorparameters to support only the necessary sensor functions at any givenstate of the device.

A wearable electronic device that is configured to control and command avariety of wireless devices within its proximity is described in U.S.Pat. No. 7,605,714 to Thompson et al. entitled: “System and method forcommand and control of wireless devices using a wearable device”, whichis incorporated in its entirety for all purposes as if fully set forthherein. The wearable device dynamically generates a user interfacecorresponding to the services of a particular wireless device. Throughthe user interface, the wireless device surface content to a user andallows a user select interactions with the wireless devices using thewearable device.

An apparatus and method for the remote control and/or interaction-withelectronic-devices such as computers; home-entertainment-systems;media-centers; televisions; DVD-players; VCR-players; music systems;appliances; security systems; toys/games; and/or displays are describedin U.S. Pat. No. 8,508,472 to Wieder entitled: “Wearable remote controlwith a single control button”, which is incorporated in its entirety forall purposes as if fully set forth herein. A user may orient a pointer(e.g., laser pointer) to place a pointer-spot on/near object(s) on anactive-display(s); and/or a fixed-display(s); and/or on real-worldobject(s) within a display region or pointer-spot detection-region.Detectors, imager(s) and/or camera(s) may be connected/attached to thedisplay region and/or a structure that is connected/attached to displayregion. When the user initiates a “select”, the detectors/cameras maydetect the location of the pointer-spot within the display region.Corresponding to the user's selection(s); control action(s) may beperformed on the device(s) being controlled/interacted-with andadditional selection-menus may be optionally presented on anactive-display.

A hand-worn controller consisting of a housing having a central openingsized to permit the controller to be worn as ring on the index finger ofa human hand is described in U.S. Patent Application Publication No.2006/0164383 to Machin et al. entitled: “Remote controller ring for userinteraction”, which is incorporated in its entirety for all purposes asif fully set forth herein. A joystick lever projects outwardly from saidhousing and is positioned to be manipulated by the user's thumb. Thejoystick operates on or more control devices, such as switches orpotentiometers, that produce control signals. A wireless communicationsdevice, such as a Bluetooth module, mounted in said housing transmitscommand signals to a remote utilization device, which are indicative ofthe motion or position of said joystick lever.

A wearable augmented reality computing apparatus with a display screen,a reflective device, a computing device and a head mounted harness tocontain these components is described in U.S. Patent ApplicationPublication No. 2012/0050144 to Morlock entitled: “Wearable augmentedreality computing apparatus”, which is incorporated in its entirety forall purposes as if fully set forth herein. The display device andreflective device are configured such that a user can see the reflectionfrom the display device superimposed on the view of reality. Anembodiment uses a switchable mirror as the reflective device. One usageof the apparatus is for vehicle or pedestrian navigation. The portabledisplay and general purpose computing device can be combined in a devicesuch as a smartphone. Additional components consist of orientationsensors and non-handheld input devices.

In one example, a wearable device may use, or may be based on, aprocessor or a microcontroller that is designed for wearableapplications, such as the CC2650 SimpleLink™ Multistandard Wireless MCUavailable from Texas Instruments Incorporated (headquartered in Dallas,Tex., U.S.A.) and described in a Texas Instrument 2015 publication #SWRT022 entitled: “SimpleLink™ Ultra-Low Power—Wireless MicrocontrollerPlatform”, and in a Texas Instrument 2015 datasheet # SWRS158A(published February 2015, Revised October 2015) entitled: “CC2650SimpleLink™ Multistandard Wireless MCU”, which are both incorporated intheir entirety for all purposes as if fully set forth herein.

An example of a personal multimedia electronic device, and moreparticularly to a head-worn device such as an eyeglass frame, isdescribed in U.S. Patent Application No. 2010/0110368 to Chaum entitled:“System and apparatus for eyeglass appliance platform”, which isincorporated in its entirety for all purposes as if fully set forthherein. The device is having a plurality of interactiveelectrical/optical components. In one embodiment, a personal multimediaelectronic device includes an eyeglass frame having a side arm and anoptic frame; an output device for delivering an output to the wearer; aninput device for obtaining an input; and a processor comprising a set ofprogramming instructions for controlling the input device and the outputdevice. The output device is supported by the eyeglass frame and isselected from the group consisting of a speaker, a bone conductiontransmitter, an image projector, and a tactile actuator. The inputdevice is supported by the eyeglass frame and is selected from the groupconsisting of an audio sensor, a tactile sensor, a bone conductionsensor, an image sensor, a body sensor, an environmental sensor, aglobal positioning system receiver, and an eye tracker. In oneembodiment, the processor applies a user interface logic that determinesa state of the eyeglass device and determines the output in response tothe input and the state.

An example of an eyewear for a user is described in U.S. PatentApplication No. 2012/0050668 Howell et al. entitled: “Eyewear withtouch-sensitive input surface”, which is incorporated in its entiretyfor all purposes as if fully set forth herein. The eyewear includes aneyewear frame, electrical circuitry at least partially in the eyewearframe, and a touch sensitive input surface on the eyewear frameconfigured to provide an input to the electrical circuitry to perform afunction via touching the touch sensitive input surface. In anotherembodiment, the eyewear includes a switch with at least two operationalstates. The operational states of the switch can be configured to bechanged by sliding a finger across the touch sensitive input surface ofthe frame.

An example of a wearable computing device is described in U.S. PatentApplication No. 2013/0169513 to Heinrich et al. entitled: “Wearablecomputing device”, which is incorporated in its entirety for allpurposes as if fully set forth herein. The device includes a boneconduction transducer, an extension arm, a light pass hole, and aflexible touch pad input circuit. When a user wears the device, thetransducer contacts the user's head. A display is attached to a free endof an extension arm. The extension arm is pivotable such that a distancebetween the display and the user's eye is adjustable to provide thedisplay at an optimum position. The light pass hole may include a lightemitting diode and a flash. The touch pad input circuit may be adheredto at least one side arm such that parting lines are not providedbetween edges of the circuit and the side arm.

Hearing aid. A hearing aid is a small electronic device this wear in orbehind a human ear to make some sounds louder so that a person withhearing loss can listen, communicate, and participate more fully indaily activities. A hearing aid can help people hear more in both quietand noisy situations. A hearing aid has three basic parts: a microphone,amplifier, and speaker. The hearing aid receives sound through amicrophone, which converts the sound waves to electrical signals andsends them to an amplifier. The amplifier increases the power of thesignals and then sends them to the ear through a speaker.

As described by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, NationalInstitutes of Health (NIH), National Institute on Deafness and OtherCommunication Disorders (NIDCD) publication No. 99-4340 September 2013Reprinted July 2015 entitled: “NIDCD Fact Sheet|Hearing and Balance”,which is incorporated in its entirety for all purposes as if fully setforth herein, there are three basic styles of hearing aids, two of whichshown in FIG. 2a . The styles differ by size, their placement on orinside the ear, and the degree to which they amplify sound.

Behind-the-ear (BTE) hearing aids shown in a view 25 in FIG. 2a consistof a hard plastic case worn behind the ear and connected to a plasticearmold that fits inside the outer ear. The electronic parts are held inthe case behind the ear. Sound travels from the hearing aid through theearmold and into the ear. A new kind of BTE aid (‘Mini’ BTE) is anopen-fit hearing aid. Small, open-fit aids fit behind the earcompletely, with only a narrow tube inserted into the ear canal,enabling the canal to remain open. For this reason, open-fit hearingaids may be a good choice for people who experience a buildup of earwax,since this type of aid is less likely to be damaged by such substances.In addition, some people may prefer the open-fit hearing aid becausetheir perception of their voice does not sound “plugged up.”

In-The-Ear (ITE) hearing aids shown in a view 26 in FIG. 2a fitcompletely inside the outer ear and are used for mild to severe hearingloss. The case holding the electronic components is made of hardplastic. Some ITE aids may have certain added features installed, suchas a telecoil. A telecoil is a small magnetic coil that allows users toreceive sound through the circuitry of the hearing aid, rather thanthrough its microphone. This makes it easier to hear conversations overthe telephone. A telecoil also helps people hear in public facilitiesthat have installed special sound systems, called induction loopsystems. Induction loop systems can be found in many churches, schools,airports, and auditoriums. ITE aids usually are not worn by youngchildren because the casings need to be replaced often as the ear grows.

The term ‘client’ typically refers to an application (or a deviceexecuting the application) used for retrieving or rendering resources,or resource manifestations, such as a web browser, an e-mail reader, ora Usenet reader, while the term ‘server’ typically refers to anapplication (or a device executing the application) used for supplyingresources or resource manifestations, and typically offers (or hosts)various services to other network computers and users. These servicesare usually provided through ports or numbered access points beyond theserver's network address. Each port number is usually associated with amaximum of one running program, which is responsible for handlingrequests to that port. A daemon, being a user program, can in turnaccess the local hardware resources of that computer by passing requeststo the operating system kernel.

A mobile operating system (also referred to as mobile OS), is anoperating system that operates a smartphone, tablet, PDA, or anothermobile device. Modern mobile operating systems combine the features of apersonal computer operating system with other features, including atouchscreen, cellular, Bluetooth, Wi-Fi, GPS mobile navigation, camera,video camera, speech recognition, voice recorder, music player, nearfield communication and infrared blaster. Currently, the popular mobileOSs include Android, Symbian, Apple iOS, BlackBerry, MeeGo, WindowsPhone, and Bada. Mobile devices with mobile communications capabilities(e.g. smartphones) typically contain two mobile operating systems: amain user-facing software platform is supplemented by a second low-levelproprietary real-time operating system that operates the radio and otherhardware.

Android is a Linux-based, open source mobile operating system (OS) basedon the Linux kernel that is currently offered by Google. With a userinterface based on direct manipulation, Android is designed primarilyfor touchscreen mobile devices such as smartphones and tablet computerswith specialized user interfaces for televisions (Android TV), cars(Android Auto), and wrist watches (Android Wear). The OS uses touchinputs that loosely correspond to real-world actions, such as swiping,tapping, pinching, and reverse pinching to manipulate on-screen objects,and a virtual keyboard. Despite being primarily designed for touchscreeninput, it also has been used in game consoles, digital cameras, andother electronics. The response to user input is designed to beimmediate and provides a fluid touch interface, often using thevibration capabilities of the device to provide haptic feedback to theuser. Internal hardware such as accelerometers, gyroscopes, andproximity sensors are used by some applications to respond to additionaluser actions. For example, adjusting the screen from portrait tolandscape depending on the device orientation, or allowing the user tosteer a vehicle in a racing game by rotating the device, a process thatsimulates control of a steering wheel.

Android devices boot to the homescreen, the primary navigation andinformation point on the device, which is similar to the desktop foundon PCs. The homescreens on Android are typically made up of app iconsand widgets. App icons launch the associated app, whereas widgetsdisplay live, auto-updating content such as the weather forecast, theuser's email inbox, or a news ticker directly on the homescreen. Ahomescreen may be made up of several pages that the user can swipe backand forth between pages. A heavily-customizable Android homescreeninterface allows the user to adjust the look and feel of the device totheir liking. Third-party apps available on Google Play and other appstores can extensively re-theme the homescreen, and even mimic the lookof other operating systems, such as Windows Phone. The Android OS isdescribed in a publication entitled: “Android Tutorial”, downloaded fromtutorialspoint.com on July 2014, which is incorporated in its entiretyfor all purposes as if fully set forth herein.

iOS (previously iPhone OS) from Apple Inc. (headquartered in Cupertino,Calif., U.S.A.) is a mobile operating system distributed exclusively forApple hardware. The user interface of the iOS is based on the concept ofdirect manipulation, using multi-touch gestures. Interface controlelements consist of sliders, switches, and buttons. Interaction with theOS includes gestures such as swipe, tap, pinch, and reverse pinch, allof which have specific definitions within the context of the iOSoperating system and its multi-touch interface. Internal accelerometersare used by some applications to respond to shaking the device (onecommon result is the undo command), or rotating it in three dimensions(one common result is switching from portrait to landscape mode). TheiOS is described in a publication entitled: “IOS Tutorial”, downloadedfrom tutorialspoint.com on July 2014, which is incorporated in itsentirety for all purposes as if fully set forth herein.

RTOS. A Real-Time Operating System (RTOS) is an Operating System (OS)intended to serve real-time applications that process data as it comesin, typically without buffer delays. Processing time requirements(including any OS delay) are typically measured in tenths of seconds orshorter increments of time, and is a time bound system which has welldefined fixed time constraints. Processing is commonly to be done withinthe defined constraints, or the system will fail. They either are eventdriven or time sharing, where event driven systems switch between tasksbased on their priorities while time sharing systems switch the taskbased on clock interrupts. A key characteristic of an RTOS is the levelof its consistency concerning the amount of time it takes to accept andcomplete an application's task; the variability is jitter. A hardreal-time operating system has less jitter than a soft real-timeoperating system. The chief design goal is not high throughput, butrather a guarantee of a soft or hard performance category. An RTOS thatcan usually or generally meet a deadline is a soft real-time OS, but ifit can meet a deadline deterministically it is a hard real-time OS. AnRTOS has an advanced algorithm for scheduling, and includes a schedulerflexibility that enables a wider, computer-system orchestration ofprocess priorities. Key factors in a real-time OS are minimal interruptlatency and minimal thread switching latency; a real-time OS is valuedmore for how quickly or how predictably it can respond than for theamount of work it can perform in a given period of time.

Common designs of RTOS include event-driven, where tasks are switchedonly when an event of higher priority needs servicing; called preemptivepriority, or priority scheduling, and time-sharing, where task areswitched on a regular clocked interrupt, and on events; called roundrobin. Time sharing designs switch tasks more often than strictlyneeded, but give smoother multitasking, giving the illusion that aprocess or user has sole use of a machine. In typical designs, a taskhas three states: Running (executing on the CPU); Ready (ready to beexecuted); and Blocked (waiting for an event, I/O for example). Mosttasks are blocked or ready most of the time because generally only onetask can run at a time per CPU. The number of items in the ready queuecan vary greatly, depending on the number of tasks the system needs toperform and the type of scheduler that the system uses. On simplernon-preemptive but still multitasking systems, a task has to give up itstime on the CPU to other tasks, which can cause the ready queue to havea greater number of overall tasks in the ready to be executed state(resource starvation).

RTOS concepts and implementations are described in an Application NoteNo. RES05B00008-0100/Rec. 1.00 published January 2010 by RenesasTechnology Corp. entitled: “R8C Family—General RTOS Concepts”, in JAJATechnologfy Review article published February 2007 [1535-5535/$32.00] byThe Association for Laboratory Automation[doi:10.1016/j.jala.2006.10.016] entitled: “An Overview of Real-TimeOperating Systems”, and in Chapter 2 entitled: “Basic Concepts of RealTime Operating Systems” of a book published 2009[ISBN—978-1-4020-9435-4] by Springer Science+Business Media B.V.entitled: “Hardware-Dependent Software—Principles and Practice”, whichare all incorporated in their entirety for all purposes as if fully setforth herein.

QNX. One example of RTOS is QNX, which is a commercial Unix-likereal-time operating system, aimed primarily at the embedded systemsmarket. QNX was one of the first commercially successful microkerneloperating systems and is used in a variety of devices including cars andmobile phones. As a microkernel-based OS, QNX is based on the idea ofrunning most of the operating system kernel in the form of a number ofsmall tasks, known as Resource Managers. In the case of QNX, the use ofa microkernel allows users (developers) to turn off any functionalitythey do not require without having to change the OS itself; instead,those services will simply not run.

FreeRTOS. FreeRTOS™ is a free and open-source Real-Time Operating systemdeveloped by Real Time Engineers Ltd., designed to fit on small embeddedsystems and implements only a very minimalist set of functions: verybasic handle of tasks and memory management, and just sufficient APIconcerning synchronization. Its features include characteristics such aspreemptive tasks, support for multiple microcontroller architectures, asmall footprint (4.3 Kbytes on an ARM7 after compilation), written in C,and compiled with various C compilers. It also allows an unlimitednumber of tasks to run at the same time, and no limitation about theirpriorities as long as used hardware can afford it.

FreeRTOS™ provides methods for multiple threads or tasks, mutexes,semaphores and software timers. A tick-less mode is provided for lowpower applications, and thread priorities are supported. Four schemes ofmemory allocation are provided: allocate only; allocate and free with avery simple, fast, algorithm; a more complex but fast allocate and freealgorithm with memory coalescence; and C library allocate and free withsome mutual exclusion protection. While the emphasis is on compactnessand speed of execution, a command line interface and POSIX-like IOabstraction add-ons are supported. FreeRTOS™ implements multiple threadsby having the host program call a thread tick method at regular shortintervals.

The thread tick method switches tasks depending on priority and around-robin scheduling scheme. The usual interval is 1/1000 of a secondto 1/100 of a second, via an interrupt from a hardware timer, but thisinterval is often changed to suit a particular application. FreeRTOS™ isdescribed in a paper by Nicolas Melot (downloaded July 2015) entitled:“Study of an operating system: FreeRTOS—Operating systems for embeddeddevices”, in a paper (dated Sep. 23, 2013) by Dr. Richard Wall entitled:“Carebot PIC32 MX7ck implementation of Free RTOS”, FreeRTOS™ modules aredescribed in web pages entitled: “FreeRTOS™ Modules” published in thewww,freertos.org web-site dated 26 Nov. 2006, and FreeRTOS kernel isdescribed in a paper published 1 Apr. 7 by Rich Goyette of CarletonUniversity as part of ‘SYSC5701: Operating System Methods for Real-TimeApplications’, entitled: “An Analysis and Description of the InnerWorkings of the FreeRTOS Kernel”, which are all incorporated in theirentirety for all purposes as if fully set forth herein.

SafeRTOS. SafeRTOS was constructed as a complementary offering toFreeRTOS, with common functionality but with a uniquely designedsafety-critical implementation. When the FreeRTOS functional model wassubjected to a full HAZOP, weakness with respect to user misuse andhardware failure within the functional model and API were identified andresolved. Both SafeRTOS and FreeRTOS share the same schedulingalgorithm, have similar APIs, and are otherwise very similar, but theywere developed with differing objectives. SafeRTOS was developed solelyin the C language to meet requirements for certification to IEC61508.SafeRTOS is known for its ability to reside solely in the on-chip readonly memory of a microcontroller for standards compliance. Whenimplemented in hardware memory, SafeRTOS code can only be utilized inits original configuration, so certification testing of systems usingthis OS need not re-test this portion of their designs during thefunctional safety certification process.

VxWorks. VxWorks is an RTOS developed as proprietary software anddesigned for use in embedded systems requiring real-time, deterministicperformance and, in many cases, safety and security certification, forindustries, such as aerospace and defense, medical devices, industrialequipment, robotics, energy, transportation, network infrastructure,automotive, and consumer electronics. VxWorks supports Intelarchitecture, POWER architecture, and ARM architectures. The VxWorks maybe used in multicore asymmetric multiprocessing (AMP), symmetricmultiprocessing (SMP), and mixed modes and multi-OS (via Type 1hypervisor) designs on 32- and 64-bit processors. VxWorks comes with thekernel, middleware, board support packages, Wind River Workbenchdevelopment suite and complementary third-party software and hardwaretechnologies. In its latest release, VxWorks 7, the RTOS has beenre-engineered for modularity and upgradeability so the OS kernel isseparate from middleware, applications and other packages. Scalability,security, safety, connectivity, and graphics have been improved toaddress Internet of Things (IoT) needs.

μC/OS. Micro-Controller Operating Systems (MicroC/OS, stylized as μC/OS)is a real-time operating system (RTOS) that is a priority-basedpreemptive real-time kernel for microprocessors, written mostly in theprogramming language C, and is intended for use in embedded systems.MicroC/OS allows defining several functions in C, each of which canexecute as an independent thread or task. Each task runs at a differentpriority, and runs as if it owns the central processing unit (CPU).Lower priority tasks can be preempted by higher priority tasks at anytime. Higher priority tasks use operating system (OS) services (such asa delay or event) to allow lower priority tasks to execute. OS servicesare provided for managing tasks and memory, communicating between tasks,and timing.

Electrical sensor. Electrical sensor is a component, device or a circuitused to measure electrical quantities. Such an electrical sensor may beconductively connected to measure the electrical parameter, or may benon-conductively coupled to measure an electric-related phenomenon, suchas magnetic field or heat. Further, the average or RMS value may bemeasured.

Ampermeter. An electrical sensor may be an ampermeter (a.k.a. ammeter)that is a current sensor that measures the magnitude of the electriccurrent in a circuit or in a conductor such as a wire. Electric currentis commonly measured in Amperes, milliampers, microamperes, orkiloampers. The sensor may be an integrating ammeter (a.k.a. watt-hourmeter) where the current is summed over time, providing a current/timeproduct, which is proportional to the energy transferred. The measuredelectric current may be an Alternating Current (AC) such as a sinewave,a Direct Current (DC), or an arbitrary waveform. A galvanometer is atype of ampermeter for detecting or measuring low current, typically byproducing a rotary deflection of a coil in a magnetic field. Someampermeters use a resistor (shunt), whose voltage is directlyproportional to the current flowing through, requiring the current topass through the meter. A hot-wire ampermeter involves passing thecurrent through a wire which expands as it heats, and the expansion ismeasured. A non-conductive or non-contact current sensor may be based on‘Hall effect’ magnetic field sensor, measuring the magnetic fieldgenerated by the current to be measured. Other non-conductive currentsensors involve a current clamp or current probe, which has two jawsthat open to allow clamping around an electrical conductor, allowing formeasuring of the electric current properties (commonly AC), withoutmaking a physical contact or disconnecting the circuit. Such currentclamp commonly comprises a wire coil wounded around a split ferritering, acting as the secondary winding of a current transformer, with thecurrent-carrying conductor acting as the primary winding. Other currentsensors and related circuits are described in Zetex Semiconductors PLCapplication note “AN39—Current measurement application handbook” Issue5, January 2008, which is incorporated in its entirety for all purposesas if fully set forth herein.

Voltmeter. An electrical sensor may be a voltmeter, commonly used formeasuring the magnitude of the electric potential difference between twopoints. Electric voltage is commonly measured in volts, millivolts,microvolts, or kilovolts. The measured electric voltage may be anAlternating Current (AC) such as a sinewave, a Direct Current (DC), oran arbitrary waveform. Similarly, an electrometer may be used formeasuring electric charge (commonly in Coulomb units—C) or electricalpotential difference, with very low leakage current. The voltmetercommonly works by measuring the current through a fixed resistor, which,according to Ohm's Law, is proportional to the voltage across theresistor. A potentiometer-based voltmeter works by balancing the unknownvoltage against a known voltage in a bridge circuit. A multimeter(a.k.a. VOM—Volt-Ohm-Milliameter) as well as Digital MultiMeter (DMM),typically includes a voltmeter, an ampermeter and an ohmmeter.

Wattmeter. An electrical sensor may be a wattmeter measuring themagnitude of the active power (or the supply rate of electrical energy),commonly using watts (W), milliwatts, kilowatts, or megawatts units. Awattmeter may be based on measuring the voltage and the current, andmultiplying to calculate the power P=VI. In AC measurement, the truepower is P=VIcos(ϕ). The wattmeter may be a bolometer, used formeasuring the power of incident electromagnetic radiation via theheating of a material with a temperature-dependent electricalresistance. A sensor may be an electricity meter (or electrical energymeter) that measures the amount of electrical energy consumed by a load.Commonly, an electricity meter is used to measure the energy consumed bya single load, an appliance, a residence, a business, or anyelectrically powered device, and may provide or be the basis for theelectricity cost or billing. The electricity meter may be an AC (singleor multi-phase) or DC type, and the common unit of measurement iskilowatt-hour, however any energy related unit may be used such asJoules. Some electricity meters are based on wattmeters, whichaccumulate or average the readings, or may be based on induction.

Ohmeter. An electrical sensor may be an ohmmeter measuring theelectrical resistance, commonly measured in ohms (Ω), milliohms,kiloohms or megohms, or conductance measured in Siemens (S) units.Low-resistance measurements commonly use micro-ohmmeter, whilemegohmmeter (a.k.a. Megger) measures large value of resistance. Commonohmmeter passes a constant known current through the measured unknownresistance (or conductance), while measuring the voltage across theresistance, and deriving the resistance (or conductance) value fromOhm's law (R=V/I). A Wheatstone bridge may also be used as a resistancesensor, by balancing two legs of a bridge circuit, where one legincludes the unknown resistance (or conductance) component. Variationsof Wheatstone bridge may be used to measure capacitance, inductance,impedance, and other electrical or non-electrical quantities.

Capacitance meter. An electrical sensor may be a capacitance meter formeasuring capacitance, commonly using units of picofarads, nanofarads,microfarads, and Farads (F). A sensor may be an inductance meter formeasuring inductance, commonly using SI units of Henry (H), such asmicroHenry, milliHenry, and Henry. Further, a sensor may be an impedancemeter for measuring an impedance of a device or a circuit. A sensor maybe an LCR meter, used to measure inductance (L), capacitance (C), andresistance (R). A meter may use sourcing an AC voltage, and use theratio of the measured voltage and current (and their phase difference)through the tested device according to Ohm's law to calculate theimpedance. Alternatively or in addition, a meter may use a bridgecircuit (Similar to Wheatstone bridge concept), where variablecalibrated elements are adjusted to detect a null. The measurement maybe in a single frequency, or over a range of frequencies.

Magnetometer. An electrical sensor may be a magnetometer for measuring alocal H or B magnetic fields. The B-field (a.k.a. magnetic flux densityor magnetic induction) is measured in Tesla (T) in SI units and Gauss incgs units, and magnetic flux is measured in Weber (Wb) units. TheH-field (a.k.a. magnetic field intensity or magnetic field strength) ismeasured in ampere-turn per meter (A/m) in SI units, and in Oersteds(Oe) in cgs units. Many Smartphones contain magnetometers serving ascompasses. A magnetometer may be a scalar magnetometer, measuring thetotal strength, or may be a vector magnetometer, providing bothmagnitude and direction (relative to the spatial orientation) of themagnetic field. Common magnetometers include Hall effect sensor,magneto-diode, magneto-transistor, AMR magnetometer, GMR magnetometer,magnetic tunnel junction magnetometer, magneto-optical sensor, Lorentzforce based MEMS sensor (a.k.a. Nuclear Magnetic Resonance—NMR),Electron Tunneling based MEMS sensor, MEMS compasses, Nuclear precessionmagnetic field sensor, optically pumped magnetic field sensor, fluxgatemagnetometer, search coil magnetic field sensor, and SuperconductingQuantum Interference Device (SQUID) magnetometer. ‘Hall effect’magnetometers are based on ‘Hall probe’, which contains an indiumcompound semiconductor crystal such as indium antimonide, mounted on analuminum backing plate, and provides a voltage a voltage in response tothe measured B-field. A fluxgate magnetometer makes use of thenon-linear magnetic characteristics of a probe or sensing element thathas a ferromagnetic core. NMR and Proton Precession Magnetometers (PPM)measure the resonance frequency of protons in the magnetic field to bemeasured. SQUID meters are very sensitive vector magnetometers, based onsuperconducting loops containing Josephson junctions. The magnetometermay be Lorentz-force-based MEMS sensor, relying on the mechanical motionof the MEMS structure due to the Lorentz force acting on thecurrent-carrying conductor in the magnetic field.

Signal generator. A signal generator (a.k.a. frequency generator) is anelectronic device or circuit devices that can generate repeating ornon-repeating electronic signals (typically voltage or current), havingan analog output (analog signal generator) or a digital output (digitalsignal generator). The output signal may be based on an electricalcircuit, or may be based on a generated or stored digital data. Afunction generator is typically a signal generator which produces simplerepetitive waveforms. Such devices contain an electronic oscillator, acircuit that is capable of creating a repetitive waveform, or may usedigital signal processing to synthesize waveforms, followed by a digitalto analog converter, or DAC, to produce an analog output. Commonwaveforms are a sine wave, a saw-tooth, a step (pulse), a square, and atriangular waveforms. The generator may include some sort of modulationfunctionality such as Amplitude Modulation (AM), Frequency Modulation(FM), or Phase Modulation (PM). An Arbitrary Waveform Generators (AWGs)are sophisticated signal generators which allow the user to generatearbitrary waveforms, within published limits of frequency range,accuracy, and output level. Unlike function generators, which arelimited to a simple set of waveforms; an AWG allows the user to specifya source waveform in a variety of different ways. Logic signal generator(a.k.a. data pattern generator and digital pattern generator) is adigital signal generator that produces logic types of signals—that islogic 1's and 0's in the form of conventional voltage levels. The usualvoltage standards are: LVTTL, LVCMOS.

Processor. The term “processor” is used herein to include, but notlimited to, any integrated circuit or any other electronic device (orcollection of electronic devices) capable of performing an operation onat least one instruction, including, without limitation, amicroprocessor (μP), a microcontroller (μC), a Digital Signal Processor(DSP), or any combination thereof. A processor may further be a ReducedInstruction Set Core (RISC) processor, a Complex Instruction SetComputing (CISC) microprocessor, a Microcontroller Unit (MCU), or aCISC-based Central Processing Unit (CPU). The hardware of the processormay be integrated onto a single substrate (e.g., silicon “die”), ordistributed among two or more substrates.

A non-limiting example of a processor may be 80186 or 80188 availablefrom Intel Corporation located at Santa Clara, Calif., USA. The 80186and its detailed memory connections are described in the manual“80186/80188 High-Integration 16-Bit Microprocessors” by IntelCorporation, which is incorporated in its entirety for all purposes asif fully set forth herein. Other non-limiting example of a processor maybe MC68360 available from Motorola Inc. located at Schaumburg, Ill.,USA. The MC68360 and its detailed memory connections are described inthe manual “MC68360 Quad Integrated Communications Controller—User'sManual” by Motorola, Inc., which is incorporated in its entirety for allpurposes as if fully set forth herein. While exampled above regarding anaddress bus having an 8-bit width, other widths of address buses arecommonly used, such as the 16-bit, 32-bit and 64-bit. Similarly, whileexampled above regarding a data bus having an 8-bit width, other widthsof data buses are commonly used, such as 16-bit, 32-bit and 64-bitwidth. In one example, the processor consists of, comprises, or is partof, Tiva™ TM4C123GH6PM Microcontroller available from Texas InstrumentsIncorporated (Headquartered in Dallas, Tex., U.S.A.), described in adata sheet published 2015 by Texas Instruments Incorporated[DS-TM4C123GH6PM-15842.2741, SPMS376E, Revision 15842.2741 June 2014],entitled: “Tiva™ TM4C123GH6PM Microcontroller—Data Sheet”, which isincorporated in its entirety for all purposes as if fully set forthherein, and is part of Texas Instrument's Tiva™ C Seriesmicrocontrollers family that provide designers a high-performance ARM®Cortex™-M-based architecture with a broad set of integrationcapabilities and a strong ecosystem of software and development tools.Targeting performance and flexibility, the Tiva™ C Series architectureoffers an 80 MHz Cortex-M with FPU, a variety of integrated memories andmultiple programmable GPIO. Tiva™ C Series devices offer consumerscompelling cost-effective solutions by integrating application-specificperipherals and providing a comprehensive library of software toolswhich minimize board costs and design-cycle time. Offering quickertime-to-market and cost savings, the Tiva™ C Series microcontrollers arethe leading choice in high-performance 32-bit applications. Targetingperformance and flexibility, the Tiva™ C Series architecture offers an80 MHz Cortex-M with FPU, a variety of integrated memories and multipleprogrammable GPIO. Tiva™ C Series devices offer consumers compellingcost-effective solutions.

Sensor. Any element capable of measuring or responding to a physicalphenomenon may be used as a sensor. An appropriate sensor may be adaptedfor a specific physical phenomenon, such as a sensor responsive totemperature, humidity, pressure, audio, vibration, light, motion, sound,proximity, flow rate, electrical voltage, and electrical current. Asensor may be an analog sensor having an analog signal output such asanalog voltage or current, or may have continuously variable impedance.Alternatively on in addition, a sensor may have a digital signal output.A sensor may serve as a detector, notifying only the presence of aphenomenon, such as by a switch, and may use a fixed or settablethreshold level. A sensor may measure time-dependent or space-dependentparameters of a phenomenon. A sensor may measure time-dependencies or aphenomenon such as the rate of change, time-integrated or time-average,duty-cycle, frequency or time period between events. A sensor may be apassive sensor, or an active sensor requiring an external source ofexcitation. A sensor may be semiconductor-based, and may be based onMEMS technology.

A sensor may measure the amount of a property or of a physical quantityor the magnitude relating to a physical phenomenon, body or substance.Alternatively or in addition, a sensor may be used to measure the timederivative thereof, such as the rate of change of the amount, thequantity or the magnitude. In the case of space related quantity ormagnitude, a sensor may measure the linear density, surface density, orvolume density, relating to the amount of property per volume.Alternatively or in addition, a sensor may measure the flux (or flow) ofa property through a cross-section or surface boundary, the fluxdensity, or the current. In the case of a scalar field, a sensor maymeasure the quantity gradient. A sensor may measure the amount ofproperty per unit mass or per mole of substance. A single sensor may beused to measure two or more phenomena.

A sensor may provide an electrical output signal in response to aphysical, chemical, biological or any other phenomenon, serving as astimulus to the sensor. A sensor may serve as, or be, a detector, fordetecting the presence of the phenomenon. Alternatively or in addition,a sensor may measure (or respond to) a parameter of a phenomenon or amagnitude of the physical quantity thereof. For example, a sensor may bea thermistor or a platinum resistance temperature detector, a lightsensor, a pH probe, a microphone for audio receiving, or a piezoelectricbridge. Similarly, a sensor may be used to measure pressure, flow, forceor other mechanical quantities. A sensor output may be amplified by anamplifier connected to the sensor output. Other signal conditioning mayalso be applied in order to improve the handling of the sensor output oradapting it to the next stage or manipulating, such as attenuation,delay, current or voltage limiting, level translation, galvanicisolation, impedance transformation, linearization, calibration,filtering, amplifying, digitizing, integration, derivation, and anyother signal manipulation. Some sensors conditioning involves connectingthem in a bridge circuit. In the case of conditioning, the conditioningcircuit may added to manipulate the sensor output, such as filter orequalizer for frequency related manipulation such as filtering, spectrumanalysis or noise removal, smoothing or de-blurring in case of imageenhancement, a compressor (or de-compressor) or coder (or decoder) inthe case of a compression or a coding/decoding schemes, modulator ordemodulator in case of modulation, and extractor for extracting ordetecting a feature or parameter such as pattern recognition orcorrelation analysis. In case of filtering, passive, active or adaptive(such as Wiener or Kalman) filters may be used. The conditioningcircuits may apply linear or non-linear manipulations. Further, themanipulation may be time-related such as analog or digital delay-lines,integrators, or rate-based manipulation. A sensor may have analogoutput, requiring an A/D to be connected thereto, or may have digitaloutput. Further, the conditioning may be based on the book entitled:“Practical Design Techniques for Sensor Signal Conditioning”, by AnalogDevices, Inc., 1999 (ISBN-0-916550-20-6), which is incorporated in itsentirety for all purposes as if fully set forth herein.

Alternatively or in addition, any sensor herein, any sensor technologyherein, any sensor conditioning herein or handling circuits, or anysensor application herein, may be according to the book entitled:“Sensors and Control Systems in manufacturing”, Second Edition 2010, bySabrie Soloman, The McGraw-Hill Companies, ISBN: 978-0-07-160573-1,according to the book entitled: “Fundamentals of IndustrialInstrumentation and Process Control”, by William C. Dunn, 2005, TheMcGraw-Hill Companies, ISBN: 0-07-145735-6, or according to the bookentitled: “Sensor technology Handbook”, Edited by Jon Wilson, byNewnes-Elsevier 2005, ISBN:0-7506-7729-5, which are all incorporated intheir entirety for all purposes as if fully set forth herein. Further, asensor may be any sensor described in U.S. Patent ApplicationPublication No. 2013/0201316 to Binder et al., entitled: “System andMethod for Server Based Control”, which is incorporated in its entiretyfor all purposes as if fully set forth herein.

A sensor may directly or indirectly measure the rate of change of thephysical quantity (gradient) versus the direction around a particularlocation, or between different locations. For example, a temperaturegradient may describe the differences in the temperature betweendifferent locations. Further, a sensor may measure time-dependent ortime-manipulated values of the phenomenon, such as time-integrated,average or Root Mean Square (RMS or rms), relating to the square root ofthe mean of the squares of a series of discrete values (or theequivalent square root of the integral in a continuously varying value).Further, a parameter relating to the time dependency of a repeatingphenomenon may be measured, such as the duty-cycle, the frequency(commonly measured in Hertz—Hz) or the period. A sensor may be based onthe Micro Electro-Mechanical Systems—MEMS (a.k.a. Micro-mechanicalelectrical systems) technology. A sensor may respond to environmentalconditions such as temperature, humidity, noise, vibration, fumes,odors, toxic conditions, dust, and ventilation.

A sensor may be an active sensor, requiring an external source ofexcitation. For example, resistor-based sensors such as thermistors andstrain gages are active sensors, requiring a current to pass throughthem in order to determine the resistance value, corresponding to themeasured phenomenon. Similarly, a bridge circuit based sensors areactive sensors depending or external electrical circuit for theiroperation. Alternatively or in addition, a sensor may be a passivesensor, generating an electrical output without requiring any externalcircuit or any external voltage or current. Thermocouples andphotodiodes are examples or passive sensors.

A sensor may measure the amount of a property or of a physical quantityor the magnitude relating to a physical phenomenon, body or substance.Alternatively or in addition, a sensor may be used to measure the timederivative thereof, such as the rate of change of the amount, thequantity or the magnitude. In the case of space related quantity ormagnitude, a sensor may measure the linear density, relating to theamount of property per length, a sensor may measure the surface density,relating to the amount of property per area, or a sensor may measure thevolume density, relating to the amount of property per volume.Alternatively or in addition, a sensor may measure the amount ofproperty per unit mass or per mole of substance. In the case of a scalarfield, a sensor may further measure the quantity gradient, relating tothe rate of change of property with respect to position. Alternativelyor in addition, a sensor may measure the flux (or flow) of a propertythrough a cross-section or surface boundary. Alternatively or inaddition, a sensor may measure the flux density, relating to the flow ofproperty through a cross-section per unit of the cross-section, orthrough a surface boundary per unit of the surface area. Alternativelyor in addition, a sensor may measure the current, relating to the rateof flow of property through a cross-section or a surface boundary, orthe current density, relating to the rate of flow of property per unitthrough a cross-section or a surface boundary. A sensor may include orconsists of a transducer, defined herein as a device for convertingenergy from one form to another for the purpose of measurement of aphysical quantity or for information transfer. Further, a single sensormay be used to measure two or more phenomena. For example, twocharacteristics of the same element may be measured, each characteristiccorresponding to a different phenomenon.

A sensor output may have multiple states, where the sensor state isdepending upon the measured parameter of the sensed phenomenon. A sensormay be based on a two state output (such as ‘0’ or ‘1’, or ‘true’ and‘false’), such as an electric switch having two contacts, where thecontacts can be in one of two states: either “closed” meaning thecontacts are touching and electricity can flow between them, or “open”,meaning the contacts are separated and the switch is non-conducting. Asensor may be a threshold switch, where the switch changes its stateupon sensing that the magnitude of the measured parameter of aphenomenon exceeds a certain threshold. For example, a sensor may be athermostat is a temperature-operated switch used to control a heatingprocess. Another example is a voice operated switch (a.k.a. VOX), whichis a switch that operates when sound over a certain threshold isdetected. It is usually used to turn on a transmitter or recorder whensomeone speaks and turn it off when they stop speaking. Another exampleis a mercury switch (also known as a mercury tilt switch), which is aswitch whose purpose is to allow or interrupt the flow of electriccurrent in an electrical circuit in a manner that is dependent on theswitch's physical position or alignment relative to the direction of the“pull” of earth's gravity, or other inertia. The threshold of athreshold based switch may be fixed or settable. Further, an actuatormay be used in order to locally or remotely set the threshold level.

In some cases, a sensor operation may be based on generating a stimulusor an excitation to generate influence or create a phenomenon. Theentire or part of the generating or stimulating mechanism may be in thiscase an integral part of the sensor, or may be regarded as independentactuators, and thus may be controlled by the controller. Further, asensor and an actuator, independent or integrated, may be cooperativelyoperating as a set, for improving the sensing or the actuatingfunctionality. For example, a light source, treated as an independentactuator, may be used to illuminate a location, in order to allow animage sensor to faithfully and properly capture an image of thatlocation. In another example, where a bridge is used to measureimpedance, the excitation voltage of the bridge may be supplied from apower supply treated and acting as an actuator.

A sensor may be a piezoelectric sensor, where the piezoelectric effectis used to measure pressure, acceleration, strain or force. Depending onhow the piezoelectric material is cut, there are three main modes ofoperation: transverse longitudinal and shear. In the transverse effectmode, a force applied along an axis generates charges in a directionperpendicular to the line of force, and in the longitudinal effect mode,the amount of charge produced is proportional to the applied force andis independent of size and shape of the piezoelectric element. Whenusing as a pressure sensor, commonly a thin membrane is used to transferthe force to the piezoelectric element, while in accelerometer use, amass is attached to the element, and the load of the mass is measured. Apiezoelectric sensor element material may be a piezoelectric ceramics(such as PZT ceramic) or a single crystal material. A single crystalmaterial may be gallium phosphate, quartz, tourmaline, or Lead MagnesiumNiobate-Lead Titanate (PMN-PT).

A sensor may be a solid state sensor, which is typically a semiconductordevice and which have no mobile parts, and commonly enclosed as a chip.The sensor may be according to, or based on, the sensor described inU.S. Pat. No. 5,511,547 to Markle, entitled: “Solid State Sensors”, inU.S. Pat. No. 6,747,258 to Benz et al., entitled: “Intensified HybridSolid-State Sensor with an Insulating Layer”, in U.S. Pat. No. 5,105,087to Jagielinski, entitled: “Large Solid State Sensor Assembly Formed fromSmaller Sensors”, or in U.S. Pat. No. 4,243,631 to Ryerson, entitled:“Solid State Sensor”, which are all incorporated in their entirety forall purposes as if fully set forth herein.

A sensor may be a nanosensor, which is a biological, chemical orphysical sensor constructed using nanoscale components, usuallymicroscopic or submicroscopic in size. A nanosensor may be according to,or based on, the sensor described in U.S. Pat. No. 7,256,466 to Lieberet al., entitled: “Nanosensors”, in U.S. Patent Application PublicationNo. 2007/0264623 to Wang et al., entitled: “Nanosensors”, in U.S. PatentApplication Publication No. 2011/0045523 to Strano et al., entitled:“Optical Nenosensors Comprising Photoluminescent Nanostructures”, or inU.S. Patent Application Publication No. 2011/0275544 to Zhou et al.,entitled: “Microfluidic Integration with Nanosensor Platform”, which areall incorporated in their entirety for all purposes as if fully setforth herein.

A sensor may include one or more sensors, each providing an electricaloutput signal (such as voltage or current), or changing a characteristic(such as resistance or impedance) in response to a measured or detectedphenomenon. The sensors may be identical, similar or different from eachother, and may measure or detect the same or different phenomena. Two ormore sensors may be connected in series or in parallel. In the case of achanging characteristic sensor or in the case of an active sensor, theunit may include an excitation or measuring circuits (such as a bridge)to generate the sensor electrical signal. The sensor output signal maybe conditioned by a signal conditioning circuit. The signal conditionermay involve time, frequency, or magnitude related manipulations. Thesignal conditioner may be linear or non-linear, and may include anoperation or an instrument amplifier, a multiplexer, a frequencyconverter, a frequency-to-voltage converter, a voltage-to-frequencyconverter, a current-to-voltage converter, a current loop converter, acharge converter, an attenuator, a sample-and-hold circuit, apeak-detector, a voltage or current limiter, a delay line or circuit, alevel translator, a galvanic isolator, an impedance transformer, alinearization circuit, a calibrator, a passive or active (or adaptive)filter, an integrator, a deviator, an equalizer, a spectrum analyzer, acompressor or a de-compressor, a coder (or decoder), a modulator (ordemodulator), a pattern recognizer, a smoother, a noise remover, anaverage or RMS circuit, or any combination thereof. In the case ofanalog sensor, an analog to digital (A/D) converter may be used toconvert the conditioned sensor output signal to a digital sensor data.The unit may include a computer for controlling and managing the unitoperation, processing the digital sensor data and handling the unitcommunication. The unit may include a modem or transceiver coupled to anetwork port (such as a connector or antenna), for interfacing andcommunicating over a network.

Methods and devices are provided for electrical neural blockade andstimulation of dysfunctional or transferred nerves and are described inU.S. Patent Application Publication No. 2019/0022383 to Hadlock et al.entitled: “Electrical Neural Blockade and Functional Stimulation ofDysfunctional or Transferred Nerves”, which is incorporated in itsentirety for all purposes as if fully set forth herein. For example, amethod is provided including identifying a dysfunctional or transferrednerve, attaching an electrode array to the dysfunctional or transferrednerve proximal to the target musculature, delivering an electricalneural blockade signal, and stimulating the dysfunctional or transferrednerve distal to the point of neural blockade. A system is also providedwith an electrode array configured to attach proximally to adysfunctional or transferred nerve and deliver an electrical neuralblockade signal with a neuromuscular stimulating electrode array placeddistal to the point of neural blockade, and a processor in communicationwith the electrode arrays and configured to provide stimulationinstructions based on the detected activity of the otherneuromusculature. A method is further provided for identifying andtreating dysfunction arising from aberrant neural regeneration for whichcontralateral paired neuromusculature exists.

Elicitation of eye closure and other movements via electricalstimulation may provide effective treatment for facial paralysis. Asurvey performed on a human feasibility study to determine whethertranscutaneous neural stimulation can elicit a blink in individuals withacute facial palsy and to obtain feedback from participants regardingthe tolerability of surface electrical stimulation for daily blinkrestoration. The survey results are provided in an article entitled:“Electrical Stimulation of Eye Blink in Individuals with Acute FacialPalsy: Progress toward a Bionic Blink” by Alice Frigerio, M.D., Ph.D.,James T. Heaton, Ph.D., Paolo Cavallari, M.D., Ph.D., Chris Knox, B.S.,Marc H. Hohman, M.D., and Tessa A. Hadlock, M.D. (Milan, Italy; andBoston, Mass.), and published October 2015 in Plastic and ReconstructiveSurgery Journal [DOI: 10.1097/PRS.0000000000001639] and presented inpart at the 2013 International Facial Nerve Symposium, in Boston, Mass.,Jun. 28 through Jul. 2, 2013, which is incorporated in its entirety forall purposes as if fully set forth herein. The Method included fortyindividuals with acute unilateral facial paralysis, HB grades 4 through6, that were prospectively studied between 6 and 60 days of onset.Unilateral stimulation of zygomatic facial nerve branches to elicit eyeblink was achieved with brief bipolar, charge-balanced pulse trains,delivered transcutaneously by adhesive electrode placement; results wererecorded on a high-speed video camera. The relationship betweenstimulation parameters and cutaneous sensation was analyzed using theWong-Baker Faces Pain Rating Scale. Complete eye closure was achieved in55 percent of participants using stimulation parameters reported astolerable. In those individuals, initial eye twitch was observed at anaverage current of 4.6 mA (±1.7; average pulse width of 0.7 ms, 100 to150 Hz), with complete closure requiring a mean of 7.2 mA (±2.6).Conclusions: Transcutaneous facial nerve stimulation may artificiallyelicit eye blink in a majority of patients with acute facial paralysis.Although individuals varied widely in their reported degrees ofdiscomfort from blink-eliciting stimulation, most of them indicated thatsuch stimulation would be tolerable if it could restore eye closure.These patients would therefore benefit from a biomimetic device tofacilitate eye closure until the recovery process is complete.

Facial palsy is a devastating condition potentially amenable torehabilitation by functional electrical stimulation. A novel paradigmfor unilateral facial reanimation using an implantable neuroprostheticdevice is proposed and its feasibility demonstrated in a live rodentmodel as described in an article entitled: “Toward the Bionic Face: ANovel Neuroprosthetic Device Paradigm for Facial Reanimation Consistingof Neural Blockade and Functional Electrical Stimulation” by NateJowett, M.D., Robert E. Kearney, Ph.D., Christopher J. Knox, B.S., andTessa A. Hadlock, M.D. (of Boston, Mass., U.S.A. and Montreal, Quebec,Canada) that was published in Volume 143, Number 1 of the Plastic andReconstructive Surgery Journal [DOI: 10.1097/PRS.0000000000005164] andPresented as part at the 2016 Annual Meeting of the American Society forPeripheral Nerve, in Scottsdale, Ariz., which is incorporated in itsentirety for all purposes as if fully set forth herein. The paradigmcomprises use of healthy-side electromyographic activity as controlinputs to a system whose outputs are neural stimuli to effect symmetricfacial displacements. The vexing issue of suppressing undesirableactivity resulting from aberrant neural regeneration (synkinesis) ornerve transfer procedures is addressed using proximal neural blockade.Methods: Epimysial and nerve cuff electrode arrays were implanted in thefaces of Wistar rats. Stimuli were delivered to evoke blinks and whisksof various durations and amplitudes. The dynamic relation betweenelectromyographic signals and facial displacements was modeled, andmodel predictions were compared against measured displacements. Optimalparameters to achieve facial nerve blockade by means of high-frequencyalternating current were determined, and the safety of continuousdelivery was assessed. Results: Electrode implantation was welltolerated. Blinks and whisks of tunable amplitudes and durations wereevoked by controlled variation of neural stimuli parameters. Facialdisplacements predicted from electromyographic input modelling matchedthose observed with a variance-accounted-for exceeding 96 percent.Effective and reversible facial nerve blockade in awake behaving animalswas achieved, without detrimental effect noted from long-term continualuse. Conclusions: Proof-of-principle of rehabilitation of hemifacialpalsy by means of a neuroprosthetic device has been demonstrated. Theuse of proximal neural blockade coupled with distal functionalelectrical stimulation may have relevance to rehabilitation of otherperipheral motor nerve deficits.

Systems and methods for detecting a user's facial movement andexpression are featured in U.S. Pat. No. 9,625,251 to Heaton et al.entitled: “Facial movement and expression detection and stimulation”,which is incorporated in its entirety for all purposes as if fully setforth herein. The systems and methods include a plurality of radiationsources, a plurality of radiation detectors, where each radiationdetector is paired with a different one of the radiation sources andconfigured to detect radiation emitted by its paired radiation source,and a controller connected to the radiation detectors and configured toreceive signals corresponding to measurements of emitted radiation fromeach of the radiation detectors, determine, for each radiationsource-detector pair, information about whether a radiation path betweenthe source and detector is blocked by a portion of the user's face, anddetermine a facial movement or expression of the user based on theinformation.

A system and method of treating hyperactivity of an eyelid closingmuscle in a subject after facial nerve paralysis is described in U.S.Patent Application Publication No. 2013/0158612 to Lindenthalerentitled: “System and Method for Eyelid Simulation”, which isincorporated in its entirety for all purposes as if fully set forthherein. The method or system includes providing a stimulation system andselectively stimulating eyelid opening muscle(s) or innervating nerves,eyelid opening reflexes, or eyelid opening reflexes in non-musculartissue, using the stimulation system, without substantially activatingthe eyelid closing muscle. The system and method evokes eyelid movementin the subject.

A method that includes evoking and recording the response of atrigeminal reflex in the presence and absence of occipital nervestimulation (ONS) is described in U.S. Patent Application PublicationNo. 2011/0264167 to Poletto entitled: “Modulation of trigeminal reflexstrength”, which is incorporated in its entirety for all purposes as iffully set forth herein. The method is used to determine whether, and towhat extent, ONS modulates the trigeminal reflex. If the ONS modulatesthe trigeminal reflex, e.g. to a sufficient degree, the subject may beconsidered a candidate for ONS for treatment of headache.

The Facial Nerve Stimulator (FNS) is a headset type device used to treatpatients with mild or severe Bell's Palsy and other facial nerveproblems, and is described in U.S. Patent Application Publication No.2008/0082131 to Llanos entitled: “Facial Nerve Stimulator (FNS)”, whichis incorporated in its entirety for all purposes as if fully set forthherein. The Facial Nerve Stimulator (FNS) is worn comfortably by restingone end on the ear lobe and inserting the Oral Electrode casing insidethe mouth. The exterior Electrode casing rests just over the mandibularcondyle. With the Oral Electrode casing inside the mouth and theexterior Electrode casing resting on the mandibular condyle, the FNSsystem is activated from a TENS unit to allow small electric pulses tostimulate both the 2nd branch (Maxillary) and the 3rd branch(mandibular) of the Trigeminal nerve as well as the mandibular condyle.

In certain variations, systems and/or methods for electromagneticinduction therapy are disclosed in U.S. Patent Application PublicationNo. 9,757,584 to BURNETT entitled: “Methods and devices for performingelectrical stimulation to treat various conditions”, which isincorporated in its entirety for all purposes as if fully set forthherein. One or more ergonomic or body contoured applicators may beincluded. The applicators include one or more conductive coilsconfigured to generate an electromagnetic or magnetic field focused on atarget nerve, muscle or other body tissues positioned in proximity tothe coil. One or more sensors may be utilized to detect stimulation andto provide feedback about the efficacy of the applied electromagneticinduction therapy. A controller may be adjustable to vary a currentthrough a coil to adjust the magnetic field focused upon the targetnerve, muscle or other body tissues based on the feedback provide by asensor or by a patient. In certain systems or methods, pulsed magneticfields may be intermittently applied to a target nerve, muscle or tissuewithout causing habituation.

Electrical stimulation patterns and methods of use thereof for treatingdry eye disease, tired eye, or other forms of ocular discomfort aredescribed in in U.S. Patent Application Publication No. 2016/0022992 toFranke et al. entitled: “Stimulation patterns for treating dry eye”,which is incorporated in its entirety for all purposes as if fully setforth herein. The methods generally include applying patternedstimulation to an anatomical structure located in an ocular region or anasal region to increase tear production.

A battery-operated transcutaneous electrical nerve stimulator (TENS) totreat headache pain in an abortive and/or preventive manner is describedin in U.S. Pat. No. 8,560,075 to Covalin entitled: “Apparatus and methodfor the treatment of headache”, which is incorporated in its entiretyfor all purposes as if fully set forth herein. The TENS unit and itselectrodes are built into a unitary device which facilitates aself-administered treatment. In some embodiments, the pulses aremonophasic. In other embodiments, pairs of biphasic pulses are provided,wherein each pair of biphasic pulses includes a first pulse having afirst polarity separated by a gap in time from a second pulsed having anopposite polarity. In some embodiments, each pulse in each biphasic pairis of a duration equal to that of the other pulse of the pair. In someembodiments, the duration of each pulse is between about 50 microsecondsand about 400 microseconds, and the gap in time between pulses of a pairis between about 50 and 100 microseconds.

A method, apparatus, and system for affecting neuromodulation based uponan evoking signal applied to a patient's body are disclosed in U.S.Patent Application Publication No. 2007/0179557 to Maschino et al.entitled: “Controlling neuromodulation using stimulus modalities”, whichis incorporated in its entirety for all purposes as if fully set forthherein. An internal and/or external evoking and/or therapeutic signal isapplied to a first target portion of a patient's body. Data relating toa physiological response resulting from the internal and/or externalevoking and/or therapeutic signal is received. A neurotransmissioncharacteristic of the patient's body is determined based upon the datarelating to the physiological response. At least one parameter definingan electrical therapeutic signal provided by an implantable medicaldevice is controlled based upon the determined neurotransmissioncharacteristic to treat a disorder.

An implantable miniature eyelid electrode apparatus that causes aparalyzed eyelid to close or open by passing an electrical stimulatingcurrent to a nerve or muscle is described in U.S. Patent ApplicationPublication No. 2003/0023297 to Byers et al. entitled: “Miniatureimplantable array and stimulation system suitable for eyelidstimulation”, which is incorporated in its entirety for all purposes asif fully set forth herein. The apparatus is comprised of alongitudinally flexible, nonconductive body containing electrodes thatpass an electrical signal to the nearby nerve or muscle, which closes oropens the eyelid. The apparatus is electrically actuated by a sourcethat may be located remotely from the apparatus. The electrical signalpasses along wires from the source to the apparatus. The apparatus isbiocompatible with the environment in the living tissue and iselectrically insulated from the surrounding tissue, except where theelectrodes contact the living tissue. The apparatus is very small and isnot obvious to visual inspection when implanted

A system for trigeminal nerve stimulation is disclosed in U.S. PatentApplication Publication No. 2014/0081353 to Cook et al. entitled: “Pulsegenerator for cranial nerve stimulation”, which is incorporated in itsentirety for all purposes as if fully set forth herein. In oneembodiment, the system includes a storage medium, a pulse generator incommunication with the storage medium, a power source coupled to thepulse generator, and at least one electrode communicatively coupled tothe pulse generator. The pulse generator includes a microcontrollerwhich executes instructions from the storage medium and themicrocontroller is configured to perform at least one of the followingoperations: produce electrical pulses having defined characteristics,record a log of use and anomalous events, restrict use to a specifiedindividual, interface with electrodes, provide a signal to the specifiedindividual indicating operational conditions and trouble conditions, andprovide a signal to the specified individual indicating an end of atreatment period.

See for example U.S. Pat. No. 8,060,208 entitled “Action potentialconduction prevention,” U.S. Pat. No. 8,843,188 entitled “Adjustablenerve electrode,” U.S. Pat. No. 8,983,614 entitled “Onset-mitigatinghigh-frequency nerve block,” U.S. Pat. No. 9,008,800 entitled“Separated-interface nerve electrode,” and U.S. Pat. No. 9,119,966entitled “Systems and methods that provide an electrical waveform forneural stimulation or nerve block,” all of which are incorporated hereinby reference in their entirety.

In consideration of the foregoing, it would be an advancement in the artto provide a method, device, or a system for transcutaneous nervestimulation such as facial nerve stimulation, and in particular, forusing transcutaneous nerve stimulation for artificially eliciting eyeblink, a smile, or other facial muscle activity, such as with humanswith acute facial paralysis, such as Bell's palsy, or with Dry eyesyndrome. Preferably, such methods, devices, or systems may be providingan improved elicitation of eye closure and are discomfort or paintolerable, simple, secure, cost-effective, reliable, easy to install,use or monitor, has a minimum part count, enclosed in a small housing,minimum hardware, and/or using existing and available components,protocols, programs and applications, that enable better control,security (or additional functionalities), and providing a better userexperience.

SUMMARY

A device may be used for artificially stimulating a nerve in a humanbody, and maybe used with a network over a medium. Any device herein maycomprise a controllable pulse generator for generating a bursts trainsignal; a sensor that may output a sensor signal in response to aphysical phenomenon; a port for coupling to the medium; a transceivercoupled to the port for transmitting digital data to, and for receivingdigital data from, the network; two electrodes attachable to a humanbody and connected to the pulse generator for coupling bursts trainsignal to the human body for periodically stimulating the nerve;software and a processor for executing the software, the processor iscoupled to the sensor for receiving the sensor signal therefrom, to thetransceiver for receiving the digital data from the network therefrom,and to control and activate the controllable pulse generator; a powersource for supplying Direct Current (DC) power to the controllable pulsegenerator, the sensor, the transceiver, and the processor; and a singlewearable enclosure housing the pulse generator, the sensor, thetransceiver, the port, the processor, and the power source. Any pulsegenerator herein may be controlled or activated in response to thesensor signal or the received digital data from the network.

Any device herein may further be integrated with, may be attached to,may be part of, may be used with, may be the basis of, or may beincluded in, a commercial available off-the-shelf TranscutaneousElectrical Nerve Stimulation (TENS) device. Any commercial availableoff-the-shelf TENS device may integrate, may be attached to, may be partof, or may comprises, any device herein. Any sensor herein may comprise,or may consist of, an eye blink detector. Any nerve herein may be afacial nerve, and any electrodes herein may be attachable to the humanbody scalp, so that when attached, may elicit eye blinking bystimulating the facial nerve. Any device herein may be used forovercoming facial nerve paralysis or Bell's palsy, for Dry eye syndrome,or for Electrical Muscle Stimulation (EMS).

Any power source herein may consist of, or may comprise, a primary or arechargeable battery, and any device herein may further comprise abattery compartment for housing the battery. Any power source herein mayconsist of, or may comprise, a rechargeable battery, and any deviceherein may further comprise a battery charger for charging therechargeable battery. Any device herein may be operative to contactlesscharging the rechargeable battery, the contactless charging may be basedon induction, and any battery charger herein may further comprise aninduction coil for receiving AC power and charging the rechargeablebattery when the device is disposed in an electromagnetic field. Anydevice herein may be operative to be powered by kinetic energy, and anybattery charger herein may include a kinetic energy to an electricalenergy converter. Any converter herein may comprise a coil and amagnetic field, and a relative movement of the coil and the magneticfield may generate power in response to the device motion.

Any device herein may further comprise an electric sensor that may beconnectable to the electrodes for measuring an electrical parameter bythe electrodes. Any electric sensor herein may comprise, may consist of,or may be based on, an impedance meter for measuring an impedancebetween the electrodes. Any the impedance meter may comprise, mayconsist of, or may be based on, an ohmmeter measuring an electricalresistance, wherein the impedance meter comprises, consists of, or isbased on, a capacitance meter for measuring capacitance, wherein theimpedance meter comprises, consists of, or is based on, an inductancemeter for measuring inductance, or any combination thereof. Any pulsegenerator may be activated or deactivated in response to the measuredelectrical parameter. Alternatively or in addition, any parameter or anycharacteristic of the bursts train signal may be set in response to anymeasured electrical parameter, such as the peak-to-peak amplitude, theamplitude nominal value, the amplitude effective value, the signalfrequency in at least one of, or in all of, the bursts, the duration ofat least one of, or in all of, the bursts, or the period between atleast two consecutive bursts, or between any two consecutive bursts, ofthe bursts train signal. Any electric sensor herein may be periodicallyconnected to the electrodes for measuring the electrical parameter bythe electrodes, and any electric sensor herein may be connected to theelectrodes between two consecutive bursts. Any device herein may furthercomprise a switch having two states, and any switch herein may becoupled to be controlled by the processor and may be operative to be indistinct first and second states. In the first state, the electrodes maybe connected to the pulse generator for receiving the bursts trainsignal therefrom, and in the first state the electrodes may be connectedto the electric sensor for measuring the electric parameter. Any switchherein may comprise, or may consist of, a single pole double throw(SPDT) switch.

Any device herein may operative for operating of an operating systemthat is included in the software. Any operating system herein may be isa mobile operating system, such as Android version 2.2 (Froyo), Androidversion 2.3 (Gingerbread), Android version 4.0 (Ice Cream Sandwich),Android Version 4.2 (Jelly Bean), Android version 4.4 (KitKat), AppleiOS version 3, Apple iOS version 4, Apple iOS version 5, Apple iOSversion 6, Apple iOS version 7, Microsoft Windows® Phone version 7,Microsoft Windows® Phone version 8, Microsoft Windows® Phone version 9,or Blackberry® operating system. Any operating system herein may beReal-Time Operating System (RTOS), such as FreeRTOS, SafeRTOS, QNX,VxWorks, or Micro-Controller Operating Systems (μC/OS).

Any of the bursts in the signal herein may comprise, or may consist of,one or more asymmetrical Bi-Phasic square current or voltage pulses. Anycontrollable pulse generator herein may comprise, or may consist of, acontinuous signal generator and an electrically controlled switchconnected in series with the continuous signal generator output. Anyswitch herein may comprise a control port that may be coupled to becontrolled by the processor.

Any electrically controlled switch herein may be based on, may comprise,or may consist of, an electrical circuit that may comprise a relay, anopen collector transistor, an open drain transistor, a thyristor, aTRIAC, or an opto-isolator. Any electrically controlled switch hereinmay be based on, may comprise, or may consist of, an electrical circuitor a transistor. Any transistor herein may be a field-effect powertransistor, and any switch herein may be formed between a ‘drain’ and a‘source’ pins, and the control port is a ‘gate’ pin. Any field-effectpower transistor herein may be an N-channel or a P-channel field-effectpower transistor. Any relay herein may be a solenoid-basedelectromagnetic relay or a reed relay, a solid-state or semiconductorbased relay, or an AC Solid State Relay (SSR).

Any pulse generator herein may be a current generator, and thepeak-to-peak amplitude, the nominal value, or the effective value, of atleast one burst may be above 0.1 milliamper (mA), 0.2 mA, 0.5 mA, 0.8mA, 1 mA, 1.2 mA, 1.5 mA, 1.8 mA, 2 mA, 2.5 mA, 3 mA, 3.5 mA, 4 mA, 4.5mA, 5 mA, 5.5 mA, 6 mA, 7 mA, 8 mA, 9 mA, 10 mA, 11 ma, 12 mA, 15 mA,18mA, 20 mA, 22 mA, 25 mA, 30 mA, 35 mA, 40 mA, 45 mA, 50 mA, 55 mA, 60mA, 65 mA, 70 mA, 75 mA, 80 mA, or 100 mA. Alternatively or in addition,any pulse generator herein may be a current generator, and thepeak-to-peak amplitude, the nominal value, or the effective value, of atleast one burst may be below 0.1 milliamper (mA), 0.2 mA, 0.5 mA, 0.8mA, 1 mA, 1.2 mA, 1.5 mA, 1.8 mA, 2 mA, 2.5 mA, 3 mA, 3.5 mA, 4 mA, 4.5mA, 5 mA, 5.5 mA, 6 mA, 7 mA, 8 mA, 9 mA, 10 mA, 11 ma, 12 mA, 15 mA,18mA, 20 mA, 22 mA, 25 mA, 30 mA, 35 mA, 40 mA, 45 mA, 50 mA, 55 mA, 60mA, 65 mA, 70 mA, 75 mA, 80 mA, or 100 mA. Any pulse generator hereinmay be a voltage generator, and the peak-to-peak amplitude, the nominalvalue, or the effective value, of at least one burst may be above 0.1millivolt (mV), 0.2 mV, 0.5 mV, 0.8 mV, 1 mV, 1.2 mV, 1.5 mV, 1.8 mV, 2mV, 2.5 mV, 3 mV, 3.5 mV, 4 mV, 4.5 mV, 5 mV, 5.5 mV, 6 mV, 7 mV, 8 mV,9 mV, 10 mV, 11 mV, 12 mV, 15 mV, 18mV, 20 mV, 22 mV, 25 mV, 30 mV, 35mV, 40 mV, 45 mV, 50 mV, 55 mV, 60 mV, 65 mV, 70 mV, 75 mV, 80 mV, or100 mV. Alternatively or in addition, any pulse generator herein may bea voltage generator, and the peak-to-peak amplitude, the nominal value,or the effective value, of at least one burst may be below 0.1 millivolt(mV), 0.2 mV, 0.5 mV, 0.8 mV, 1 mV, 1.2 mV, 1.5 mV, 1.8 mV, 2 mV, 2.5mV, 3 mV, 3.5 mV, 4 mV, 4.5 mV, 5 mV, 5.5 mV, 6 mV, 7 mV, 8 mV, 9 mV, 10mV, 11 mV, 12 mV, 15 mV, 18mV, 20 mV, 22 mV, 25 mV, 30 mV, 35 mV, 40 mV,45 mV, 50 mV, 55 mV, 60 mV, 65 mV, 70 mV, 75 mV, 80 mV, or 100 mV.

Alternatively or in addition, any pulse generator herein may be avoltage generator, and the peak-to-peak amplitude, the nominal value, orthe effective value, of at least one burst may be more than 0.1 Volts(V), 0.2 V, 0.5 V, 0.8 V, 1 V, 1.2 V, 1.5 V, 1.8 V, 2 V, 2.5 V, 3 V, 3.5V, 4 V, 4.5 V, 5 V, 5.5 V, 6 V, 7 V, 8 V, 9 V, 10 V, 11 V, 12 V, 15 V,18V, 20 V, 22 V, 25 V, 30 V, 35 V, 40 V, 45 V, 50 V, 55 V, 60 V, 65 V,70 V, 75 V, 80 V, or 100 V. Alternatively or in addition, any pulsegenerator herein may be a voltage generator, and the peak-to-peakamplitude, the nominal value, or the effective value, of at least oneburst may be less than 0.1 Volts (V), 0.2 V, 0.5 V, 0.8 V, 1 V, 1.2 V,1.5 V, 1.8 V, 2 V, 2.5 V, 3 V, 3.5 V, 4 V, 4.5 V, 5 V, 5.5 V, 6 V, 7 V,8 V, 9 V, 10 V, 11 V, 12 V, 15 V, 18V, 20 V, 22 V, 25 V, 30 V, 35 V, 40V, 45 V, 50 V, 55 V, 60 V, 65 V, 70 V, 75 V, 80 V, or 100 V.

Any duration herein of at least one of, or in all of, the bursts of thebursts train signal may be more than 1 milliseconds (ms), 2 ms, 3 ms, 5ms, 7 ms, 10 ms, 12 ms, 15 ms, 18 ms, 20 ms, 25 ms, 30 ms, 40 ms, 45 ms,50 ms, 100 ms, 120 ms, 150 ms, 180 ms, 200 ms, 250 ms, 300 ms, 400 ms,450 ms, or 500 ms. Alternatively or in addition, any duration of atleast one of, or in all of, the bursts of the bursts train signal may beless than 1 milliseconds (ms), 2 ms, 3 ms, 5 ms, 7 ms, 10 ms, 12 ms, 15ms, 18 ms, 20 ms, 25 ms, 30 ms, 40 ms, 45 ms, 50 ms, 100 ms, 120 ms, 150ms, 180 ms, 200 ms, 250 ms, 300 ms, 400 ms, 450 ms, or 500 ms.

Any signal frequency herein in at least one of, or in all of, the burstsof the bursts train signal may be more than 1 Hertz (Hz), 2 Hz, 5 Hz, 8Hz, 10 Hz, 12 Hz, 15 Hz, 18 Hz, 20 Hz, 22 Hz, 25 Hz, 30 Hz, 35 Hz, 50Hz, 60 Hz, 70 Hz, 80 Hz, 100 Hz, 120 Hz, 150 Hz, 180 Hz, 200 Hz, 250 Hz,300 Hz, 350 Hz, 400 Hz, or 500 Hz. Alternatively or in addition, anysignal frequency herein in at least one of, or in all of, the bursts ofthe bursts train signal may be less than 1 Hertz (Hz), 2 Hz, 5 Hz, 8 Hz,10 Hz, 12 Hz, 15 Hz, 18 Hz, 20 Hz, 22 Hz, 25 Hz, 30 Hz, 35 Hz, 50 Hz, 60Hz, 70 Hz, 80 Hz, 100 Hz, 120 Hz, 150 Hz, 180 Hz, 200 Hz, 250 Hz, 300Hz, 350 Hz, 400 Hz, or 500 Hz.

Any period herein between at least two consecutive bursts, or betweenany two consecutive bursts, may be more than 100 milliseconds (ms), 120ms, 150 ms, 180 ms, 200 ms, 250 ms, 300 ms, 400 ms, 450 ms, 500 ms, 700ms, 1,000 (ms), 1,200 ms, 1,500 ms, 1,800 ms, 2,000 ms, 2,500 ms, 3,000ms, 3,500 ms, 4,000 ms, 4,500 ms, 5,000 ms, 6,000 ms, 6,500 ms, 7,000ms, 7,500 ms, 8,000 ms, 8,500 ms, 9,000 ms, or 9,500 ms. Alternativelyor in addition, any period herein between at least two consecutivebursts, or between any two consecutive bursts, may be less than 100milliseconds (ms), 120 ms, 150 ms, 180 ms, 200 ms, 250 ms, 300 ms, 400ms, 450 ms, 500 ms, 700 ms, 1,000 (ms), 1,200 ms, 1,500 ms, 1,800 ms,2,000 ms, 2,500 ms, 3,000 ms, 3,500 ms, 4,000 ms, 4,500 ms, 5,000 ms,6,000 ms, 6,500 ms, 7,000 ms, 7,500 ms, 8,000 ms, 8,500 ms, 9,000 ms, or9,500 ms.

Any device herein any comprise a random number generator that may becoupled to the processor for producing a random number or signal, andany bursts train signal herein may be in response to the random number.Any random number generator herein may be hardware based, and may beusing thermal noise, shot noise, nuclear decaying radiation,photoelectric effect, or quantum phenomena. Any random number generatorherein may be software based, and may be based on executing an algorithmfor generating pseudo-random numbers. Any pulse generator herein may beactivated or deactivated in response to the random number. Any parameteror any characteristic herein of any bursts train signal may be set inresponse to the random number, and any parameter herein may comprise thepeak-to-peak amplitude, the amplitude nominal value, the amplitudeeffective value, the signal frequency in at least one of, or in all of,the bursts, the duration of at least one of, or in all of, the bursts,or the period between at least two consecutive bursts, or between anytwo consecutive bursts, of the bursts train signal.

Any wearable enclosure herein may be wearable on the human body, such aswearable on an organ of the person head that may be an eye, ear, face,cheek, nose, mouth, lip, forehead, or chin. Any enclosure herein may beconstructed to have a form substantially similar to, is constructed tohave a shape allowing mounting or wearing identical or similar to, or isconstructed to have a form to at least in part substitute for, headwear,eyewear, or earpiece. Any headwear herein may consist of, may bestructured as, or may comprise, a bonnet, a cap, a crown, a fillet, ahair cover, a hat, a helmet, a hood, a mask, a turban, a veil, or a wig.Any eyewear herein may consist of, may be structured as, or maycomprise, glasses, sunglasses, a contact lens, a blindfold, or a goggle.Any earpiece herein may consist of, may be structured as, or maycomprise, a hearing aid, a headphone, a headset, or an earplug. Anyenclosure herein may be permanently or releseably attachable to, or maybe part of, a clothing piece of a person, and the attaching may usetaping, gluing, pinning, enclosing, encapsulating, a pin, or a latch andhook clip. Any clothing piece herein may be a top, bottom, or full-bodyunderwear, or a headwear, a footwear, an accessory, an outwear, a suit,a dress, or a skirt. Any device herein may further comprise an annularmember defining an aperture therethrough that is sized for receipttherein of a part of a human body, and the human body part may be partof a human hand that may consist of, or may comprise, an upper arm,elbow, forearm, wrist, or a finger.

Any human body part herein may be part of a human head or neck that mayconsist of, or may comprise, a forehead, ear, skull, or face. Further,any human body part herein may be part of a human thorax or abdomen thatmay consist of, or may comprise, a waist or hip. Any human body partherein may be part of a human leg or foot that may consist of, or maycomprise, a thigh, calf, ankle, instep, knee, or toe. Any singleenclosure herein may be shaped or structured as Behind-the-ear (BTE),‘Mini’ BTE, or In-The-Ear (ITE) enclosure. Any enclosure herein may beconstructed to have a form substantially similar to that of a standardhearing aid; a wearable element substantially similar to those of astandard hearing aid; a shape allowing direct mounting in or on theexternal ear; or a form to at least in part substitute for a standardhearing aid. Further, any enclosure herein may be constructed to have aform substantially similar to that of a standard headphone or earplug;wearable elements substantially similar to those of a standard headphoneor earplug; a shape allowing direct mounting in or on the head; or aform to at least in part substitute for a standard headphone or earplug.

Any electrodes herein may be EEG or ECG electrodes, or may be optimizedor configured to primarily serve as Electroencephalography (EEG) or anElectrocardiography (ECG) electrodes. Any electrodes herein may bemechanically attached or coupled to each other, and any device hereinmay further comprise an electrodes assembly that may comprise a singlestructure attached to the two electrodes, the assembly may furthercomprise a connector for connecting to the wearable enclosure, and theassembly may further determine the distance between the electrodes. Anyconnector herein may comprise, or may consist of, a slim connector or aZero Force connector (ZIF), and any device herein may further comprise aflexible cable for connecting the electrodes assembly to the enclosure.Each of the electrodes herein may be a skin electrode that may comprisea substantially flat and round conductive pad, having a surface area ofthe conductive pad that may be above 1 square millimeters (mm²), 2 mm²,3 mm², 5 mm², 8 mm², 10 mm², 12 mm², 15 mm², 17 mm², 20 mm², 22 mm², 25mm², 30 mm², or 50 mm², or the surface area of the conductive pad may beless than 2 square millimeters (mm²), 3 mm², 5 mm², 8 mm², 10 mm², 12mm², 15 mm², 17 mm², 20 mm², 22 mm², 25 mm², 30 mm², 50 mm², or 100 mm².Upon attaching to the scalp, the distance between the centers or edgesof any two electrodes conductive pads herein may be less than 5millimeter (mm), 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm,50 mm, 70 mm, or 100 mm.

Upon attaching to the scalp, the distance between the centers or edgesof any two electrodes conductive pads herein may be more than 4millimeter (mm), 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm,50 mm, 70 mm, or 90 mm. Each of the electrodes herein may be based on,may comprise, or may consist of, flexible, stretchable, printed circuit.Each of the electrodes herein may be based on, may comprise, or mayconsist of, a patterned conductive material printed on an adhesive filmthat is attachable to a human skin. Each of the electrodes herein may bebased on, may comprise, or may consist of, a ‘tattoo’ electrode that maybe based on, may comprise, or may consist of, a conductive materiallaminated between adhesive polymer films. Each of the electrodes hereinmay be based on, may comprise, or may consist of, an implantableelectrode or an implanted electrode.

Any electrodes herein may be attached to a human face, such as to affector stimulate a facial nerve in the human face, for example to affect orstimulate the Zygomatic branch, the Temporal Branch, or both. Each ofthe electrodes herein may include a conductive area that may be attachedto the human face, and any conductive area herein may define a centerpoint. Any device herein may be used with an imaginary line defined bythe shortest path between a right eye and a right ear, or between a lefteye and a left ear, of the human face, and one of the electrodes hereinmay be located so that part of, most of, or all of, the conductive areais above the imaginary line. Alternatively or in addition, any one ofthe electrodes herein may be located so that part of, most of, or allof, the conductive area is below the imaginary line. The center point ofat least one of the electrodes may be above or below the imaginary line.

The center point of at least one of the electrodes herein may be at adistance from the imaginary line that may be at least 1 millimeter (mm),2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 15 mm, 30 mm, 40 mm,50 mm, 70 mm, or 100 mm. Alternatively or in addition, the center pointof the at least one of the electrodes herein may be at a distance fromthe imaginary line that may be less than 2 millimeter (mm), 3 mm, 5 mm,7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, 100mm, or 120 mm. Any device herein may be used with a first line that isperpendicular to the imaginary line and passes through the center pointof one of the electrodes, and a second line that is perpendicular to theimaginary line and passes through the center point of the otherelectrode, and the distance between the first and second lines may beequal to, or less than, 1 millimeter (mm), 2 mm, 3 mm, 5 mm, 7 mm, 10mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, or 100 mm,or the distance between the first and second lines may be equal to, ormore than, 0 mm, 1 millimeter (mm), 2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, 100 mm, or 120 mm.

Any pulse generator herein may be activated or deactivated in responseto digital data received from the network. Any parameter or anycharacteristic of any of the bursts train signal herein may be set inresponse to digital data received from the network. Any parameter hereinmay comprise the peak-to-peak amplitude, the amplitude nominal value,the amplitude effective value, the signal frequency in at least one of,or in all of, the bursts, the duration of at least one of, or in all of,the bursts, or the period between at least two consecutive bursts, orbetween any two consecutive bursts, of the bursts train signal.

Any pulse generator herein may be activated or deactivated in responseto the sensor signal. Any device herein may be used with a minimum ormaximum value, and any pulse generator may be activated or deactivatedin response to the sensor signal being below the minimum value, or anypulse generator may be activated or deactivated in response to thesensor signal being above the maximum value. Any parameter or anycharacteristic of any bursts train signal herein may be set in responseto the sensor signal. Any parameter herein may comprise the peak-to-peakamplitude, the amplitude nominal value, the amplitude effective value,the signal frequency in at least one of, or in all of, the bursts, theduration of at least one of, or in all of, the bursts, or the periodbetween at least two consecutive bursts, or between any two consecutivebursts, of the bursts train signal.

Any device herein may be further operative to send a message to thenetwork, and any network herein may be a wireless network, and anyherein message may be sent over the Internet via the wireless network.Any message herein may be sent over the Internet via the wirelessnetwork to an Instant Messaging (IM) server for being sent to a clientdevice as part of an IM service. The message or the communication withthe IM server may be using, or may be based on, SMTP (Simple MailTransfer Protocol), SIP (Session Initiation Protocol), SIMPLE (SIP forInstant Messaging and Presence Leveraging Extensions), APEX (ApplicationExchange), Prim (Presence and Instance Messaging Protocol), XMPP(Extensible Messaging and Presence Protocol), IMPS (Instant Messagingand Presence Service), RTMP (Real Time Messaging Protocol), STM (SimpleTCP/IP Messaging) protocol, Azureus Extended Messaging Protocol, ApplePush Notification Service (APNs), or Hypertext Transfer Protocol (HTTP).

Any message herein may be a text-based message and the IM service may bea text messaging service. Any message herein may be according to, or maybe based on, a Short Message Service (SMS) message and the IM service isa SMS service, the message is according to, or based on, anelectronic-mail (e-mail) message and the IM service is an e-mailservice, the message is according to, or based on, WhatsApp message andthe IM service is a WhatsApp service, the message is according to, orbased on, an Twitter message and the IM service is a Twitter service, orthe message is according to, or based on, a Viber message and the IMservice is a Viber service. Any message herein may be a MultimediaMessaging Service (MMS) or an Enhanced Messaging Service (EMS) messagethat may include an audio or video, and the IM service may berespectively a NMS or EMS service. Any device herein may be used with aminimum or maximum value, and any message may be sent in response to thesensor signal being below the minimum value, or the message may be sentin response to the sensor signal being above the maximum value.

Any device herein may be addressable in the network, such as in theInternet, using a digital address. Any digital address herein may be aMAC layer address that is MAC-48, EUI-48, or EUI-64 address type.Alternatively or in addition, any digital address herein may be a layer3 address and is static or dynamic IP address that is IPv4 or IPv6 typeaddress.

Any network herein may comprise, may use, or may consist of, a wirelessnetwork, any port herein may comprise, may use, or may consist of, anantenna for transmitting and receiving first Radio-Frequency (RF)signals over the air; and any transceiver herein may comprise, may use,or may consist of, a wireless transceiver coupled to the antenna forwirelessly transmitting and receiving the digital data over the airusing the wireless network. Any wireless network herein may be aWireless Wide Area Network (WWAN), such as wireless broadband network,any wireless transceiver herein may be a WWAN transceiver, and anyantenna herein may be a WWAN antenna. Any wireless network herein may bea WiMAX network, any antenna herein may be a WiMAX antenna and anywireless transceiver herein may be a WiMAX modem, and the WiMAX networkmay be according to, or may be based on, IEEE 802.16-2009. Any wirelessnetwork herein may be a cellular telephone network, any antenna hereinmay be a cellular antenna, and any wireless herein transceiver may be acellular modem, and any cellular telephone network herein may be a ThirdGeneration (3G) network that uses UMTS W-CDMA, UMTS HSPA, UMTS TDD,CDMA2000 1xRTT, CDMA2000 EV-DO, or GSM EDGE-Evolution, or wherein thecellular telephone network is a Fourth Generation (4G) network that usesHSPA+, Mobile WiMAX, LTE, LTE-Advanced, MBWA, or is may be based on IEEE802.20-2008.

Any wireless network herein may be a Wireless Personal Area Network(WPAN), any wireless transceiver herein may be a WPAN transceiver, andany antenna herein may be a WPAN antenna. Any WPAN herein may beaccording to, or may be based on, Bluetooth™ Bluetooth Low Energy (BLE),or IEEE 802.15.1-2005 standards, or any WPAN may be a wireless controlnetwork that may be according to, or may be based on, Zigbee™, IEEE802.15.4-2003, or Z-Wave™ standards. Any wireless network herein may bea Body Area Network (BAN), such as according to, or based on, IEEE802.15.6 standard, and any wireless transceiver herein may be a BANtransceiver, and any antenna herein may be a BAN antenna.

Any wireless network herein may be a Wireless Local Area Network (WLAN),such as according to, or based on, IEEE 802.11-2012, IEEE 802.11a, IEEE802.11b, IEEE 802.11g, IEEE 802.11n, or IEEE 802.116ac, and any wirelesstransceiver herein may be a WLAN transceiver, and any antenna herein maybe a WLAN antenna. Any wireless network herein may be over a licensed orunlicensed radio frequency band. Any wireless network herein may be inthe unlicensed radio frequency band is an Industrial, Scientific andMedical (ISM) radio band. Any wireless transceiver herein may beoperative to communicate in an ad-hok scheme. Any device herein may beused with an intermediary device, and the wireless transceiver may beoperative to communicate with the intermediary device using aninfrastructure scheme, and the intermediary device may be a WirelessAccess Point (WAP), a wireless switch, or a wireless router.

Any sensor herein may be a physiological sensor that may respond toparameters associated with the human body, and may be external to thesensed body, implanted inside the sensed body, attached to the sensedbody, or wearable on the sensed body. Any physiological sensor hereinmay be responding to body electrical signals and may be an EEGElectroencephalography (EEG) or an Electrocardiography (ECG) sensor, ormay be responding to oxygen saturation, gas saturation, or a bloodpressure in the sensed body.

Any sensor herein may be an electric sensor that responds to anelectrical characteristics or electrical phenomenon quantity in anelectrical circuit, and any sensor herein may be connected for measuringa parameter or characteristic the bursts train signal, such as beingconnected in series between the pulse generator and the electrodes, orconnected in parallel to the electrodes. Any electrical sensor hereinmay be responsive to Alternating Current (AC) or Direct Current (DC).Any electrical sensor herein may be an ampermeter that responds toelectrical current passing through a conductor or wire. Any ampermeterherein may consist of, or may comprise, a galvanometer, a hot-wireampermeter, a current clamp, or a current probe. Any electrical sensorherein may be a voltmeter that responds to an electrical voltage, or awattmeter that responds to active electrical power.

Any sensor herein may be a piezoelectric sensor that may use thepiezoelectric effect, may include single crystal material or apiezoelectric ceramics, and may use transverse, longitudinal, or sheareffect mode. Any sensor herein may be a thermoelectric sensor thatresponds to a temperature or a temperature gradient that may sense thetemperature using conduction, convection, or radiation. Anythermoelectric sensor herein may consist of, or may comprise, a PositiveTemperature Coefficient (PTC) thermistor, a Negative TemperatureCoefficient (NTC) thermistor, a thermocouple, a quartz crystal, or aResistance Temperature Detector (RTD). Any device herein may comprisemultiple sensors arranged as a directional sensor array operative toestimate the number, magnitude, frequency, Direction-Of-Arrival (DOA),distance, or speed of the phenomenon impinging the sensor array, and theprocessor may be operative for processing of the sensor array outputs.

Any sensor herein may consist of, or may comprise, a nanosensor, acrystal, or a semiconductor, or wherein: the sensor is an ultrasonicbased, the sensor is an eddy-current sensor, the sensor is a proximitysensor, the sensor is a bulk or surface acoustic sensor, or the sensoris an atmospheric or an environmental sensor. Any sensor herein mayconsist of, or may comprise a radiation sensor that responds toradioactivity, nuclear radiation, alpha particles, beta particles, orgamma rays, and is based on gas ionization. Any sensor herein mayconsist of, or may comprise a photoelectric sensor that responds to avisible or an invisible light, the invisible light is infrared,ultraviolet, X-rays, or gamma rays, and wherein the photoelectric sensorconsists of, comprises, or is based on the photoelectric or photovoltaiceffect, and consists of, or comprises, a semiconductor component thatconsists of, or comprises, a photodiode, a phototransistor, or a solarcell. Any photoelectric sensor herein may consist of, may comprise, ormay be based on Charge-Coupled Device (CCD) or a ComplementaryMetal-Oxide Semiconductor (CMOS) element. Any sensor herein may consistof, or may comprise a photosensitive image sensor array comprisingmultiple photoelectric sensors, for capturing an image and producingelectronic image information representing the image, and the devicefurther comprising one or more optical lens for focusing the receivedlight and to guide the image, and any image sensor herein may bedisposed approximately at an image focal point plane of the one or moreoptical lens for properly capturing the image.

Any image processor herein may be coupled to the image sensor forproviding a digital data video signal according to a digital videoformat, the digital video signal carrying digital data video based onthe captured images, and the digital video format may be based on oneout of: TIFF (Tagged Image File Format), RAW format, AVI, DV, MOV, WMV,MP4, DCF (Design Rule for Camera Format), ITU-T H.261, ITU-T H.263,ITU-T H.264, ITU-T CCIR 601, ASF, Exif (Exchangeable Image File Format),and DPOF (Digital Print Order Format) standards. Any device herein mayfurther comprise a intraframe or interframe compression based videocompressor coupled to the image sensor for lossy or non-lossycompressing the digital data video, and any compression herein may bebased on a standard compression algorithm which may be one or more outof JPEG (Joint Photographic Experts Group) and MPEG (Moving PictureExperts Group), ITU-T H.261, ITU-T H.263, ITU-T H.264 and ITU-T CCIR601.

Any sensor herein may consist of, or may comprise, an electrochemicalsensor that responds to an object chemical structure, properties,composition, or reactions. Any electrochemical sensor herein may consistof, or may comprise, a pH meter or a gas sensor responding to a presenceof radon, hydrogen, oxygen, or Carbon-Monoxide (CO), or wherein theelectrochemical sensor consists of, comprises, or is based on opticaldetection or on ionization and is a smoke, a flame, or a fire detector,or is responsive to combustible, flammable, or toxic gas. Any sensorherein may consist of, or may comprise, an electroacoustic sensor thatresponds to an audible or inaudible sound. Any electroacoustic sensorherein may consist of, or may comprise, an omnidirectional,unidirectional, or bidirectional microphone that may consist of, maycomprise, or may be based on the sensing the incident sound based motionof a diaphragm or a ribbon, and the microphone may consist of, or maycomprise, a condenser, an electret, a dynamic, a ribbon, a carbon, or apiezoelectric microphone.

Any sensor herein may consist of, or may comprise an angular positionsensor for measuring angular setting or a change of an angle. Any sensorherein may consist of, or may comprise an absolute-pressure sensor formeasuring ranges from 50% to 500% of the earth's atmospheric pressure.Any sensor herein may be an electric sensor that may respond to anelectrical characteristics or electrical phenomenon quantity in anelectrical circuit, and may be conductively coupled to the electricalcircuit, or may be a non-contact sensor that is non-conductively coupledto the electrical circuit. Any electrical sensor herein may beresponsive to Alternating Current (AC) or Direct Current (DC), and maybe an ampermeter that responds to electrical current passing through aconductor or wire, and may consist of, or may comprise, a galvanometer,a hot-wire ampermeter, a current clamp, or a current probe.Alternatively or in addition, any electrical sensor herein may be avoltmeter that responds to an electrical voltage, and may consist of, ormay comprise, an electrometer, a resistor, a potentiometer, or a bridgecircuit. Alternatively or in addition, any electrical sensor herein maybe a wattmeter that responds to active electrical power.

Any device herein may be integrated with at least one of a wirelessdevice, a notebook computer, a laptop computer, a media player, aDigital Still Camera (DSC), a Digital video Camera (DVC or digitalcamcorder), a Personal Digital Assistant (PDA), a cellular telephone, adigital camera, a video recorder, or a smartphone. Alternatively or inaddition, any device herein may be integrated with a smartphone that maycomprise, or may be based on, an Apple iPhone 6 or a Samsung Galaxy S6.

The above summary is not an exhaustive list of all aspects of thepresent invention. Indeed, the inventor contemplates that his inventionincludes all systems and methods that can be practiced from all suitablecombinations and derivatives of the various aspects summarized above, aswell as those disclosed in the detailed description below, andparticularly pointed out in the claims filed with the application. Suchcombinations have particular advantages not specifically recited in theabove summary.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of non-limiting examples only,with reference to the accompanying drawings, wherein like designationsdenote like elements. Understanding that these drawings only provideinformation concerning typical embodiments of the invention and are nottherefore to be considered limiting in scope:

FIG. 1 depicts pictorially a person face showing Bell's palsy symptoms;

FIG. 2 depicts pictorially an electrodes assembly;

FIG. 2a depicts pictorially hearing aid enclosures;

FIG. 3 illustrates schematically a block diagram of a generalstimulating device;

FIG. 4 illustrates schematically a block diagram of a battery-poweredstimulating device using continuous pulse generator and providingwireless communication;

FIG. 4a illustrates schematically a block diagram of a battery-poweredstimulating device that includes a random number generator and anelectric meter;

FIG. 4b illustrates schematically a block diagram of a battery-poweredstimulating device that includes an impedance meter and having twostates;

FIG. 5 depicts schematically a battery-powered stimulating deviceemploying inductive battery charging;

FIG. 6 illustrates schematically a simplified flowchart of a stimulatordevice operation;

FIG. 7 depicts pictorially facial nerve branches external to the skull;and

FIG. 7a depicts pictorially electrodes location for stimulating facialnerve branches external to the skull.

DETAILED DESCRIPTION

The principles and operation of an apparatus according to the presentinvention may be understood with reference to the figures and theaccompanying description wherein similar components appearing indifferent figures are denoted by identical reference numerals. Thedrawings and descriptions are conceptual only. In actual practice, asingle component can implement one or more functions; alternatively orin addition, each function can be implemented by a plurality ofcomponents and devices. In the figures and descriptions, identicalreference numerals indicate those components that are common todifferent embodiments or configurations. Identical numerical references(even in the case of using different suffix, such as 5, 5 a, 5 b and 5c) refer to functions or actual devices that are either identical,substantially similar, or having similar functionality. It will bereadily understood that the components of the present invention, asgenerally described and illustrated in the figures herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of the embodiments of theapparatus, system, and method of the present invention, as representedin the figures herein, is not intended to limit the scope of theinvention, as claimed, but is merely the representative embodiments ofthe invention. It is to be understood that the singular forms “a,” “an,”and “the” herein include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to “a componentsurface” includes reference to one or more of such surfaces. By the term“substantially” it is meant that the recited characteristic, parameter,or value need not be achieved exactly, but that deviations orvariations, including for example, tolerances, measurement errors,measurement accuracy limitations and other factors known to those ofskill in the art, may occur in amounts that do not preclude the effectthe characteristic was intended to provide.

In one example, a stimulating device or apparatus is used to generatemodulated pulse bursts, preferably enabling adjustment of the outputsignal parameters or characteristics, offering minimum energyconsumption and minimal discomfort. The device is preferably located toeffectively couple the output signal to a nerve, such as a facial nerve,via a coupling device. The device output may be controlled manually orautomatically, and may be synchronized with the opposite eye or by apreset program. In one application, the stimulating device may be usedto generate timed eye blinking preferably by inducing muscle action toclose upper and preferably also lower eyelids, each independently or incombination, to result in complete eye closure, and with the correctphysiological ratio between lower and upper eyelids. Further, the devicemay be used to stimulate or squeeze the tear gland.

A general arrangement 30 of using a general stimulator device 31 isshown in FIG. 3, and a general arrangement 40 of using an examplaryembodiment of a stimulator device 31 a is shown in FIG. 4. The device 31comprises a Gated Pulse Generator 35 that outputs via a connection orport 38 a gated symmetrical or asymmetrical Bi-Phasic square pulsesignal 41. The signal 41 is comprised of train of square wave bursts 41d having a peak-to-peak amplitude ‘A’ 41 c and a time duration d 41 a.The pulses train 41 is periodically repeated every T 41 b seconds, andin each burst 41 d the square-wave frequency is ‘f’. The generator 35output signal 41 is carried over the connection 38 to a connector 28 bin the enclosure of the device 31. The signal 41 reaches electrodes 26 aand 26 b that are attached to a scalp of a treated person 25. Theelectrodes 26 a and 26 b are connected via wires or conductors to aconnector 27 a. A cable 29 having end connectors 28 a and 27 b connectsrespectively to the device 31 connector 28 a and electrodes structureconnector 27 b, thus forming a continuous connection from the generator35 to the person 25 skin.

The device 31 operation is controlled by a controller block 39, whichpreferably comprises a software (or firmware) and a processor forexecuting the software (or firmware). The controller 39 further controlsand set the signal 41 parameters, such as the burst duration ‘d’ 41 a,the repetition period ‘T’ 41 b, the amplitude A 41 c, the burst internalfrequency 41 d, or any combination thereof, via a connection 47 betweenthe controller 39 and the generator 35. The simulating device 31 mayfurther comprise a sensor 32 that outputs sensor data, in response to aphysical phenomenon, the sensor 32 may be coupled to transmit the sensoroutput data to the controller 39 for further handling and processing,and for acting in response to the value of the sensor 32 output.

The stimulating device 31 may further include an indicator 37 that is anoutput component for notifying or outputting information to a user,which may be the person 25 that is treated by the arrangement 30, oranother person. For example, the indicator 37 may provide auditory orvisual feedback to a human, such as to alert the user through auditorytones/beeps in advance of the presentation of information, or by changesin a display. Alternatively or in addition, the indicator 37 may includea vibrator for tactile interface with the user, such as the person 25that may wear the device 31. The indicator 37 is coupled to becontrolled or activated by the controller 39.

The stimulating device 31 may further include a user controlfunctionality 33 that is an input component for receiving information orcontrol commands from a user, which may be the person 25 that is treatedby the arrangement 30, or another person. The user control block 33 mayinclude an input component that may be a piece of computer hardwareequipment used to provide data and control signals to an informationprocessing system such as a computer or information appliance. Suchinput component may be an integrated or a peripheral input device (e.g.,hard/soft keyboard, mouse, resistive or capacitive touch display, etc.).Examples of input components include keyboards, mouse, scanners, digitalcameras and joysticks. An input components can be categorized based onthe modality of input (e.g., mechanical motion, audio, visual, etc.),whether the input is discrete (e.g. pressing of key) or continuous(e.g., a mouse's position, though digitized into a discrete quantity, isfast enough to be considered continuous), the number of degrees offreedom involved (e.g., two-dimensional traditional mice, orthree-dimensional navigators designed for CAD applications). Pointingdevices (such as ‘computer mouse’), which are input components used tospecify a position in space, can further be classified according towhether the input is direct or indirect. With direct input, the inputspace coincides with the display space, i.e., pointing is done in thespace where visual feedback or the pointer appears. Touchscreens andlight pens involve direct input. Examples involving indirect inputinclude the mouse and trackball, and whether the positional informationis absolute (e.g., on a touch screen) or relative (e.g., with a mousethat can be lifted and repositioned). Direct input is almost necessarilyabsolute, but indirect input may be either absolute or relative. Forexample, digitizing graphics tablets that do not have an embedded screeninvolve indirect input and sense absolute positions and are often run inan absolute input mode, but they may also be set up to simulate arelative input mode like that of a touchpad, where the stylus or puckcan be lifted and repositioned. Further, an input component in the usercontrol block 33 may include dedicated hard controls for frequentlyused/accessed functions (e.g., repeat system message).

The stimulating device 31 may further include a communication interface36 for transmitting data to, or for receiving data from, another deviceover a communication network. The communication interface 36 may consistof, be part of, or include, a transceiver or modem for communicationwith the network. In the case of wired networks, the communicationinterface 36 connects to the network via a port that may include aconnector, and in the case of wireless network, the communicationinterface 36 connects to the network via the port that may include anantenna. The communication interface 36 is controlled and activated bythe controller 39. Further, data received from an external device overthe communication network is transferred to the controller 39 forfurther handling, and data to be sent to an external device over thecommunication network is received at the communication interface 36 fromthe controller 39. The electronic circuits and components in thestimulating device 31 are electrically powered from a power source 34,which typically supplies a Direct Current (DC) voltage (or current).

The controller 39 may be based on a discrete logic or an integrateddevice, such as a processor, microprocessor or microcomputer, and mayinclude a general-purpose device or may be a special purpose processingdevice, such as an ASIC, PAL, PLA, PLD, Field Programmable Gate Array(FPGA), Gate Array, or other customized or programmable device. In thecase of a programmable device as well as in other implementations, amemory is required. The controller 39 commonly includes a memory thatmay include a static RAM (random Access Memory), dynamic RAM, flashmemory, ROM (Read Only Memory), or any other data storage medium. Thememory may include data, programs, and/or instructions and any othersoftware or firmware executable by the processor. Control logic can beimplemented in hardware or in software, such as a firmware stored in thememory. The controller 39 controls and monitors the device operation,such as initialization, configuration, interface, and commands. Anystep, method, or flow-chart herein may be performed by the processor inthe controller 39 as directed by the software therein.

Battery. In one example, the power source 34 may comprise, may be basedon, or may consist of, a battery. A battery may be a primary battery orcell, in which an irreversible chemical reaction that generates theelectricity, and thus the cell is disposable and cannot be recharged,and need to be replaced after the battery is drained. Such batteryreplacement may be expensive and cumbersome. Alternatively or inaddition, the battery may be a rechargeable battery 34 a, illustrated aspart of the stimulator device 31 a shown in FIG. 4, such as anickel-cadmium based battery. In such a case, a battery charger 41 isemployed for charging the battery while it is in use or not in use.Various types of such battery chargers are known in the art, such astrickle chargers, pulse chargers and the like. The battery charger maybe integrated with the field unit or be external to it. The battery maybe a primary or a rechargeable (secondary) type, may include a single orfew batteries, and may use various chemicals for the electro-chemicalcells, such as lithium, alkaline and nickel-cadmium. Common batteriesare manufactured in pre-defined standard output voltages (1.5, 3, 4.5, 9Volts, for example), as well as defined standard mechanical enclosures(usually defined by letters such as “A”, “AA”, “B”, “C” sizes), and‘coin’ or ‘button’ type. In one embodiment, the battery (or batteries)is held in a battery holder or compartment, and thus can be easilyreplaced.

A battery may be a ‘watch battery’ (a.k.a. ‘coin cell’ or ‘buttoncell’), which is a small single cell battery shaped as a squat cylindertypically 5 to 25 mm in diameter and 1 to 6 mm high. Button cells aretypically used to power small portable electronics devices such as wristwatches, pocket calculators, artificial cardiac pacemakers, implantablecardiac defibrillators, and hearing aids. Most button cells have lowself-discharge and hold their charge for a long time if not used.Higher-power devices such as hearing aids may use zinc-air cells thathave much higher capacity for a given size, but discharge over a fewweeks even if not used. Button cells are single cells, usuallydisposable primary cells. Common anode materials are zinc or lithium,and common cathode materials are manganese dioxide, silver oxide, carbonmonofluoride, cupric oxide or oxygen from the air. A metal can forms thebottom body and positive terminal of the cell, where the insulated topcap is the negative terminal.

An example of a ‘coin cell’ is designated by the InternationalElectrotechnical Commission (IEC) in the IEC 60086-3 standard (Primarybatteries, part 3 Watch batteries) as LR44 type, which is an alkaline1.5 volt button cell. The letter ‘L’ indicates the electrochemicalsystem used: a zinc negative electrode, manganese dioxide depolarizerand positive electrode, and an alkaline electrolyte. R44 indicates around cell 11.4±0.2 mm diameter and 5.2±0.2 mm height as defined by theIEC standard 60086. An example of LR44 type battery is Energizer A76battery, available from Energizer Holdings, Inc., and described in aproduct datasheet Form No. EBC—4407cp-Z (downloaded from the InternetMarch 2016) entitled: “Energizer A76—ZEROMERCURY Miniature Alkaline”,which is incorporated in its entirety for all purposes as if fully setforth herein. Another example of a ‘coin cell’ is a CR2032 battery,which is a button cell lithium battery rated at 3.0 volts. Nominaldiameter is 20 mm, nominal height is 3.2 mm. CR2032 indicates a roundcell 19.7-20 mm diameter and 2.9-3.2 mm height as defined by the IECstandard 60086. The battery weight typically ranges from 2.8 g to 3.9 g.The BR2032 battery has the same dimensions, a slightly lower nominalvoltage and capacity, and an extended temperature range compared withthe CR2032. It is rated for a temperature range of −30° C. to 85° C.,while the CR2032 is specified over the range −20° C. to 70° C. BR2032also has a much lower self-discharge rate. An example of CR2032 typebattery is Energizer CR2032 Lithium Coin battery, available fromEnergizer Holdings, Inc., and described in a product datasheet Form No.EBC—4120M (downloaded from the Internet March 2016) entitled: “EnergizerCR2032—Lithium Coin”, which is incorporated in its entirety for allpurposes as if fully set forth herein.

While the invention was exampled in FIG. 4 above with regard to a directand conductive charging, thus may require a connector, a contactlesscharging may equally be used, such as by using inductive coupling wherethe energy is transferred using an electromagnetic field. In inductivecoupling a charging station sends energy using a transmitter inductioncoil to the device to be charged, which includes a receiving inductioncoil inductively coupled to the transmitter coil. The received power iscommonly used to charge the rechargeable battery 34 a while enclosedwithin the device. In such a configuration there is no need for anyconnectors or for connector engagement, thus making it easy to use,impermeable to water and dirt and with improved shape and look. Such anarrangement of induction-based charging device 31 b capable of inductivecharging is shown in an arrangement 50 shown in FIG. 5. The receivingcoil 56 internal to the device 31 b is designed to receive energy whenproperly positioned in an electromagnetic field. The received signal isrectified by a rectifier and further processed or conditioned asrequired, as part of the battery charger 41 a that is connected via theconductors or wires 57 a and 57 b to the coil 56. The electric power isthen fed from the battery charger 41 to charge the secondary cell 34 a.Contactless battery charging systems are described in U.S. Pat. No.6,208,115 to Binder titled: “Battery Substitute Pack”, in U.S. Pat. No.7,863,859 to Soar titled: “Contactless Battery Charging Apparel”, inU.S. Pat. No. 7,872,445 to Ron Hui titled: “Rechargeable Battery PoweredPortable Electronic Device”, in U.S. Pat. No. 7,906,936 to Azancot etal. titled: “Rechargeable Inductive Charger”, in U.S. Pat. No. 7,863,861to Cheng et al. titled: “Contact-Less Power Transfer” and in U.S. Pat.No. 7,876,067 to Greenfeld et al. titled: “High Frequency Connector-LessCharging Scheme”, which are all incorporated in their entirety for allpurposes as if fully set forth herein.

As shown in the examplary arrangement 50 in FIG. 5, a device 31 b thatis capable of contactless inductive charging is used with a chargingstation 54 is shown. The device 31 b comprises a receiving coil 56,connected via wires 57 a and 57 b, hence when the coil 56 is in theelectromagnetic field generated by a coil 55 in the charger 54, therechargeable battery 34 a is charged. The coil 55 which generates theelectromagnetic field, and is fed from the AC power by the AC/DCconverter 52 having prongs 51 a and 51 b, feeding the inductivegenerator 54 via a cable 53.

In another example, the device 31 a may be locally energized. Thebattery charger 41 may comprise an electrical energy generator tolocally generate electrical power for charging the rechargeable battery34 a. Preferably, the generator may be integrated within the device 31 aenclosure. Such generator may be based on converting kinetic energyharvested from the device 31 a motion, which may be caused by a human oranimal activity, to electrical energy. Such generator is described inU.S. Pat. No. 7,692,320 to Lemieux titled: “Electrical EnergyGenerator”, in U.S. Pat. No. 5,578,877 to Tiemann titled: “Apparatus forConverting Vibratory Motion to Electrical Energy”, in U.S. Pat. No.7,847,421 to Gardner et al. titled: “System for Generating ElectricalEnergy from Ambient Motion” and in U.S. Patent Application 2007/0210580to Robets et al. titled: “Electromechanical Generator for, and Method ofConverting Mechanical Vibrational Energy into Electrical Energy”, aswell as a battery-shaped generator described in U.S. Pat. No. 7,688,036to Yarger et al. titled: “System and Method for Storing Energy”, whichare all incorporated in their entirety for all purposes as if fully setforth herein.

Any part of, or whole of, any device, apparatus, block, or functionalitydescribed herein may be integrated with, attached to, part of, usedwith, be the basis of, or included in, any commercial availableoff-the-shelf TENS device, such as the TENS 3000 or TENS 7000 availablefrom Roscoe Medical Inc. (of Middleburg Heights, Ohio, U.S.A.), or anyother nerve stimulation device described as part of the ‘BACKGROUND’section Similarly, any part of, or whole of, any device, apparatus,block, or functionality, of any commercial available off-the-shelf TENSdevice, such as the TENS 3000 or TENS 7000 available from Roscoe MedicalInc. (of Middleburg Heights, Ohio, U.S.A.), or any other nervestimulation device described as part of the ‘BACKGROUND’ section, may beintegrated with, attached to, part of, used with, be the basis of, orincluded in, any device or apparatus described herein.

The gated pulse generator 35 is a signal generator that serves as acurrent (or voltage) source for providing the bursts train 41 to theconnector 28 b of the stimulator device 31, for supplying via the cable29 to the person 25. The activation of the generator 35, as well as thecontrolling and setting of the bursts train 41 parameters may be set bythe controller 39 via the connection or port 47. Typically, the gatedpulse generator 35 supplies asymmetrical Bi-Phasic square current pulseas the bursts train 41.

The burst train 41 parameters include the peak-to-peak amplitude ‘A’ 41c (or the nominal value, or effective value, of the signal 41), theburst duration d 41 a, the frequency ‘f’ of the signal in the burst 41d, and the period T 41 b. Each of the parameters may be implemented asfixed value, and as such cannot be changed during the device 31operation. Alternatively or in addition, each of the parameters may bechanged and controlled during operation, such as by the user using theuser control 33, externally from the network via the communicationinterface 36, or in response to the sensor 32 output. Each of thechangeable parameters may be variable over a range from a minimum valueto a maximum value, as set by the controller 39 over the controlconnection or port 47.

The gated pulse generator 35 may be a voltage or current generator. Thepeak-to-peak amplitude ‘A’ 41 c, the nominal value, or effective value,of the signal 41, in case of a current generator, (or the minimum ormaximum settable value) may be above 0.1 milliamper (mA), 0.2 mA, 0.5mA, 0.8 mA, 1 mA, 1.2 mA, 1.5 mA, 1.8 mA, 2 mA, 2.5 mA, 3 mA, 3.5 mA, 4mA, 4.5 mA, 5 mA, 5.5 mA, 6 mA, 7 mA, 8 mA, 9 mA, 10 mA, 11 ma, 12 mA,15 mA, 18mA, 20 mA, 22 mA, 25 mA, 30 mA, 35 mA, 40 mA, 45 mA, 50 mA, 55mA, 60 mA, 65 mA, 70 mA, 75 mA, 80 mA, or 100 mA. Alternatively or inaddition, the peak-to-peak amplitude ‘A’ 41 c, or the nominal oreffective value, of the signal 41, in case of a current generator, (orthe minimum or maximum settable value) may be below 0.2 milliamper (mA),0.5 mA, 0.8 mA, 1 mA, 1.2 mA, 1.5 mA, 1.8 mA, 2 mA, 2.5 mA, 3 mA, 3.5mA, 4 mA, 4.5 mA, 5 mA, 5.5 mA, 6 mA, 7 mA, 8 mA, 9 mA, 10 mA, 11 ma, 12mA, 15 mA, 18mA, 20 mA, 22 mA, 25 mA, 30 mA, 35 mA, 40 mA, 45 mA, 50 mA,55 mA, 60 mA, 65 mA, 70 mA, 75 mA, 80 mA, 100 mA, or 150 mA. In case ofa voltage generator, the peak-to-peak amplitude ‘A’ 41 c, the nominalvalue, or the effective value, of the signal 41, in case of a currentgenerator, (or the minimum or maximum settable value) may be above 0.1millivolt (mV), 0.2 mV, 0.5 mV, 0.8 mV, 1 mV, 1.2 mV, 1.5 mV, 1.8 mV, 2mV, 2.5 mV, 3 mV, 3.5 mV, 4 mV, 4.5 mV, 5 mV, 5.5 mV, 6 mV, 7 mV, 8 mV,9 mV, 10 mV, 11 mV, 12 mV, 15 mV, 18mV, 20 mV, 22 mV, 25 mV, 30 mV, 35mV, 40 mV, 45 mV, 50 mV, 55 mV, 60 mV, 65 mV, 70 mV, 75 mV, 80 mV, or100 mV.

Alternatively or in addition, in case of a voltage generator, thepeak-to-peak amplitude ‘A’ 41 c, the nominal value, or the effectivevalue, of the signal 41, (or the minimum or maximum settable value) maybe below 0.2 millivolt (mV), 0.5 mV, 0.8 mV, 1 mV, 1.2 mV, 1.5 mV, 1.8mV, 2 mV, 2.5 mV, 3 mV, 3.5 mV, 4 mV, 4.5 mV, 5 mV, 5.5 mV, 6 mV, 7 mV,8 mV, 9 mV, 10 mV, 11 mV, 12 mV, 15 mV, 18mV, 20 mV, 22 mV, 25 mV, 30mV, 35 mV, 40 mV, 45 mV, 50 mV, 55 mV, 60 mV, 65 mV, 70 mV, 75 mV, 80mV, 100mV, or 150 mV.

Alternatively or in addition, in case of a voltage generator, thepeak-to-peak amplitude ‘A’ 41 c, the nominal value, or the effectivevalue, of the signal 41, in case of a current generator, (or the minimumor maximum settable value) may be above 0.1 Volts (V), 0.2 V, 0.5 V, 0.8V, 1 V, 1.2 V, 1.5 V, 1.8 V, 2 V, 2.5 V, 3 V, 3.5 V, 4 V, 4.5 V, 5 V,5.5 V, 6 V, 7 V, 8 V, 9 V, 10 V, 11 V, 12 V, 15 V, 18V, 20 V, 22 V, 25V, 30 V, 35 V, 40 V, 45 V, 50 V, 55 V, 60 V, 65 V, 70 V, 75 V, 80 V, or100 V. Alternatively or in addition, in case of a voltage generator, thepeak-to-peak amplitude ‘A’ 41 c, the nominal value, or the effectivevalue, of the signal 41, (or the minimum or maximum settable value) maybe below 0.2 Volts (V), 0.5 V, 0.8 V, 1 V, 1.2 V, 1.5 V, 1.8 V, 2 V, 2.5V, 3 V, 3.5 V, 4 V, 4.5 V, 5 V, 5.5 V, 6 V, 7 V, 8 V, 9 V, 10 V, 11 V,12 V, 15 V, 18V, 20 V, 22 V, 25 V, 30 V, 35 V, 40 V, 45 V, 50 V, 55 V,60 V, 65 V, 70 V, 75 V, 80 V, 100V, or 150 V.

The burst duration d 41 a at the gated pulse generator 35 output (or theminimum or maximum settable value) may be above 1 milliseconds (ms), 2ms, 3 ms, 5 ms, 7 ms, 10 ms, 12 ms, 15 ms, 18 ms, 20 ms, 25 ms, 30 ms,40 ms, 45 ms, 50 ms, 100 ms, 120 ms, 150 ms, 180 ms, 200 ms, 250 ms, 300ms, 400 ms, 450 ms, or 500 ms. Alternatively or in addition, the burstduration d 41 a (or the minimum or maximum settable value) may be below2 milliseconds (ms), 2 ms, 3 ms, 5 ms, 7 ms, 10 ms, 12 ms, 15 ms, 18 ms,20 ms, 25 ms, 30 ms, 40 ms, 45 ms, 50 ms, 100 ms, 120 ms, 150 ms, 180ms, 200 ms, 250 ms, 300 ms, 400 ms, 450 ms, 500 ms, or 900 ms.

The frequency ‘f’ of the signal in the burst 41 d (or the minimum ormaximum settable value) may be above 1 Hertz (Hz), 2 Hz, 5 Hz, 8 Hz, 10Hz, 12 Hz, 15 Hz, 18 Hz, 20 Hz, 22 Hz, 25 Hz, 30 Hz, 35 Hz, 50 Hz, 60Hz, 70 Hz, 80 Hz, 100 Hz, 120 Hz, 150 Hz, 180 Hz, 200 Hz, 250 Hz, 300Hz, 350 Hz, 400 Hz, or 500 Hz. Alternatively or in addition, thefrequency ‘f’ of the signal in the burst 41 d (or the minimum or maximumsettable value) may be below 2 Hertz (Hz), 5 Hz, 8 Hz, 10 Hz, 12 Hz, 15Hz, 18 Hz, 20 Hz, 22 Hz, 25 Hz, 30 Hz, 35 Hz, 50 Hz, 60 Hz, 70 Hz, 80Hz, 100 Hz, 120 Hz, 150 Hz, 180 Hz, 200 Hz, 250 Hz, 300 Hz, 350 Hz, 400Hz, 500 Hz, or 1,000 Hz.

The period T 41 b of the signal between the bursts 41 d (or the minimumor maximum settable value) may be above 100 milliseconds (ms), 120 ms,150 ms, 180 ms, 200 ms, 250 ms, 300 ms, 400 ms, 450 ms, 500 ms, 700 ms,1,000 ms, 1,200 ms, 1,500 ms, 1,800 ms, 2,000 ms, 2,500 ms, 3,000 ms,3,500 ms, 4,000 ms, 4,500 ms, 5,000 ms, 6,000 ms, 6,500 ms, 7,000 ms,7,500 ms, 8000 ms, 8500 ms, 9000 ms, or 9500 ms. Alternatively or inaddition, The period T 41 b of the signal between the bursts 41 d (orthe minimum or maximum settable value) may be below 120 ms, 150 ms, 180ms, 200 ms, 250 ms, 300 ms, 400 ms, 450 ms, 500 ms, 700 ms, 1,000 (ms),1,200 ms, 1,500 ms, 1,800 ms, 2,000 ms, 2,500 ms, 3,000 ms, 3,500 ms,4,000 ms, 4,500 ms, 5,000 ms, 6,000 ms, 6,500 ms, 7,000 ms, 7,500 ms,8,000 ms, 8,500 ms, 9,000 ms, 9,500 ms, or 10,000 ms.

In one example, the gated signal generator 35 is implemented using acontinuous pulse generator 42, which generates an output signal not asthe bursts train 41 but as continuous signal, together with a seriallyconnected controlled switch 29, which switch the continuous signal toproduce the required bursts train 41. In such a case, the peak-to-peakamplitude ‘A’ 41 c (or the nominal value, or effective value, of thesignal 41) and the frequency ‘f’ of the signal in the burst 41 d aredetermined by the continuous signal generator 42, and may be controlledor set by the controller 39 via the control port or connection 35, whilethe period T 41 b and the burst duration d 41 a are determined by thecontrolled switch 29 actuation, which may be controlled by thecontroller 39 via the connection 44 connected to the switch 29 controlport or connection 45. In one example, the switch 29 is anelectromechanical device with one or more sets of electrical contactshaving two or more states. The switch may be a ‘normally open’ type,requiring actuation for closing the contacts, may be ‘normally closed’type, where actuation affects breaking the circuit, or may be achangeover switch, having both types of contacts arrangements. Achangeover switch may be either a ‘make-before-break’ or a‘break-before-make’ type. The switch contacts may have one or more polesand one or more throws. Common switch contacts arrangements includeSingle-Pole-Single-Throw (SPST), Single-Pole-Double-Throw (SPDT),Double-Pole-Double-Throw (DPDT), Double-Pole-Single-Throw (DPST), andSingle-Pole-Changeover (SPCO). A switch may be electrically ormechanically actuated.

A relay is a non-limiting example of an electrically operated switch 29.A relay may be a latching relay, that has two relaxed states(bi-stable), and when the current is switched off, the relay remains inits last state. This is achieved with a solenoid operating a ratchet andcam mechanism, or by having two opposing coils with an over-centerspring or permanent magnet to hold the armature and contacts in positionwhile the coil is relaxed, or with a permanent core. A relay may be anelectromagnetic relay, that typically consists of a coil of wire wrappedaround a soft iron core, an iron yoke which provides a low reluctancepath for magnetic flux, a movable iron armature, and one or more sets ofcontacts. The armature is hinged to the yoke and mechanically linked toone or more sets of moving contacts. It is held in place by a spring sothat when the relay is de-energized there is an air gap in the magneticcircuit. In this condition, one of the two sets of contacts in the relaypictured is closed, and the other set is open. A reed relay is a reedswitch enclosed in a solenoid, and the switch has a set of contactsinside an evacuated or inert gas-filled glass tube, which protects thecontacts against atmospheric corrosion.

Alternatively or in addition, a relay may be a Solid State Relay (SSR),where a solid-state based component functioning as a relay, withouthaving any moving parts.

In one example, the SSR may be Part Number CPC1006N—60V Normally-OpenSingle-Pole 4-Pin SOP OptoMOS® Relay—available from IXYS IntegratedCircuits Division, headquartered in Beverly, Mass., U.S.A., described ina data-sheet No. DS-CPC1006N-R05 published Jan. 30, 2018, which isincorporated in its entirety for all purposes as if fully set forthherein. The CPC1006N is a miniature single-pole, normally-open(1-Form-A) solid state relay in a 4-pin SOP package that employsoptically coupled MOSFET technology to provide 1500 Vrms of input tooutput isolation. The relay outputs are constructed with efficientMOSFET switches and photovoltaic die that use IXYS Integrated CircuitsDivision's patented OptoMOS architecture while the input, a highlyefficient infrared LED, provides the optically coupled control.

In another example, the SSR may be controlled by an optocoupler, such asa CPC1965Y AC Solid State Relay, available from IXYS Integrated CircuitsDivision (Headquartered in Milpitas, Calif., U.S.A.) which is an ACSolid State Relay (SSR) using waveguide coupling with dual power SCRoutputs to produce an alternative to optocoupler and Triac circuits. Theswitches are robust enough to provide a blocking voltage of up to 600VP, and are tightly controlled zero-cross circuitry ensures switching ofAC loads without the generation of transients. The input and outputcircuits are optically coupled to provide 3750 Vrms of isolation andnoise immunity between control and load circuits. The CPC1965Y AC SolidState Relay is described in an IXYS Integrated Circuits Divisionspecification DS-CPC1965Y-R07 entitled: “CPC1965Y AC Solid State Relay”,which is incorporated in its entirety for all purposes as if fully setforth herein.

Alternatively or in addition, the switch 29 may be implemented using anelectrical circuit or component. For example, an open collector (or opendrain) based circuit may be used. Further, an opto-isolator (a.k.a.optocoupler, photocoupler, or optical isolator) may be used to provideisolated power transfer. Further, a thyristor such as a Triode forAlternating Current (TRIAC) may be used for triggering the power. In oneexample, the switch 29 may be based on, or consists of, a TRIAC PartNumber BTA06 available from SGS-Thomson Microelectronics is used,described in the data sheet “BTA06 T/D/S/A BTB06 T/D/S/A—Sensitive GateTriacs” published by SGS-Thomson Microelectronics March 1995, which isincorporated in its entirety for all purposes as if fully set forthherein.

In addition, the switch 29 may be based on a transistor. The transistormay be a Metal-Oxide-Semiconductor Field-Effect Transistor (MOSFET,MOS-FET, or MOS FET), commonly used for amplifying or switchingelectronic signals. The MOSFET transistor is a four-terminal componentwith source (S), gate (G), drain (D), and body (B) terminals, where thebody (or substrate) of the MOSFET is often connected to the sourceterminal, making it a three-terminal component like other field-effecttransistors. In an enhancement mode MOSFETs, a voltage drop across theoxide induces a conducting channel between the source and drain contactsvia the field effect. The term “enhancement mode” refers to the increaseof conductivity with an increase in oxide field that adds carriers tothe channel, also referred to as the inversion layer. The channel cancontain electrons (called an nMOSFET or nMOS), or holes (called apMOSFET or pMOS), opposite in type to the substrate, so nMOS is madewith a p-type substrate, and pMOS with an n-type substrate. In oneexample, the switch 29 may be based on an N-channel enhancement modestandard level field-effect transistor that features very low on-stateresistance. Such a transistor may be based on, or consists of, TrenchMOStransistor Part Number BUK7524-55 from Philips Semiconductors, describedin the Product Specifications from Philips Semiconductors “TrenchMOS™transistor Standard level FET BUK7524-55” Rev 1.000 dated January 1997,which is incorporated in its entirety for all purposes as if fully setforth herein.

Electrodes. Any type of electrodes or skin electrodes known in the artmay be used to implement electrodes 26 a and 26 b. Further, anyelectrodes assembly, in which the two electrodes are mechanicallyattached or coupled to each other and to a connector, such as theassembly 20 shown in FIG. 2 may be used, where the connector 27 a isimplemented by connector 22 of the assembly 20. Further, any type ofelectrodes or skin electrodes, and any type of electrodes assembly,known in the art to be used for Electroencephalography (EEG) or anElectrocardiography (ECG) may be used to implement the electrodes 26 aand 26 b, either as independent electrodes or as part of an electrodesassembly. Further, any type of electrodes or skin electrodes, and anytype of electrodes assembly, described for any nerve stimulation as partof the ‘BACKGROUND’ section above may as well, be used, or may be thebasis of, implementing the electrodes 26 a and 26 b, either asindependent electrodes or as part of an electrodes assembly.Alternatively or in addition, the electrodes may be implantableelectrodes. In one example, each of the skin electrodes is implementedas substantially flat and round conductive pad. The surface where theelectrodes pads touch the skin, such as the scalp, may use a conductivematerial, such as gel or carbon nano-tubes conductive layer. Preferably,the skin surface area of each electrode is 15 mm²±2 mm². In anotherexample, the skin surface area of each electrode each of the electrodesmay be above 1 square millimeters (mm²), 2 mm², 3 mm², 5 mm², 8 mm², 10mm², 12 mm², 15 mm², 17 mm², 20 mm², 22 mm², 25 mm², 30 mm², or 50 mm².Alternatively or in addition, the skin surface area of each electrodeeach of the electrodes may be less than 2 square millimeters (mm²), 3mm², 5 mm², 8 mm², 10 mm², 12 mm², 15 mm², 17 mm², 20 mm², 22 mm², 25mm², 30 mm², 50 mm², or 100 mm².

The distance between the centers or edges of the two electrodesconductive pads as part of an electrodes assembly (such as the assembly20 shown in FIG. 2), or the distance upon attaching to the scalp, may beless than 5 millimeter (mm), 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30mm, 40 mm, 50 mm, 70 mm, or 100 mm. Alternatively or in addition, thedistance between the centers or edges of the two electrodes conductivepads may be more than 4 millimeter (mm), 7 mm, 10 mm, 12 mm, 15 mm, 20mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, or 90 mm.

In one example, each electrode consists of an electrically conductiveelectrolyte gel and a silver/silver chloride conductor. Further, theelectrodes may be based on flexible, stretchable printed circuitselectrodes. Such electrodes typically consist of a patterned conductivematerial printed on an adhesive film that attaches to the skin. Inaddition, dry metallic electrodes or gelled electrodes may be used.Further, tattoo electrodes that are made of a conductive materiallaminated between adhesive polymer films may be used. The electrodes maybe part of an electrodes assembly, which may include a connector, suchas slim connector or Zero force connector (ZIF).

Wearable. Any device, component, or apparatus herein, such as the device31 shown in FIG. 3 or the device 31 a shown in FIG. 4, or any electrodeor electrode assembly herein, may be structured as, may be shaped orconfigured to serve as, or may be integrated with, a wearable device.Any apparatus or device herein may be wearable on an organ such as onthe person head, and the organ may be eye, ear, face, cheek, nose,mouth, lip, forehead, or chin. Alternatively or in addition, anyapparatus or device herein may be constructed to have a formsubstantially similar to, may be constructed to have a shape allowingmounting or wearing identical or similar to, or may be constructed tohave a form to at least in part substitute for, headwear, eyewear, orearpiece. Any headwear herein may consist of, may be structured as, ormay comprise, a bonnet, a headband, a cap, a crown, a fillet, a haircover, a hat, a helmet, a hood, a mask, a turban, a veil, or a wig. Anyeyewear herein may consist of, may be structured as, or may comprise,glasses, sunglasses, a contact lens, a blindfold, or a goggle. Anyearpiece herein may consist of, may be structured as, or may comprise, ahearing aid, a headphone, a headset, or an earplug. Alternatively or inaddition, any enclosure herein may be permanently or releaseablyattachable to, or may be part of, a clothing piece of a person. Theattaching may use taping, gluing, pinning, enclosing, encapsulating, apin, or a latch and hook clip, and the clothing piece may be a top,bottom, or full-body underwear, or a headwear, a footwear, an accessory,an outwear, a suit, a dress, a skirt, or a top. In one example, thedevice 31 enclosure may be shaped or structured as a Behind-the-ear(BTE), ‘Mini’ BTE, or In-The-Ear (ITE) enclosure.

The user control 33 may be an input component that comprises, orconsists of, a piece of computer hardware equipment used to provide dataand control signals to an information processing system such as acomputer or information appliance. Such input component 33 may be anintegrated or a peripheral input device (e.g., hard/soft keyboard,mouse, resistive or capacitive touch display, etc.). Examples of inputcomponents include keyboards, mouse, scanners, digital cameras andjoysticks. Input component 33 can be categorized based on the modalityof input (e.g., mechanical motion, audio, visual, etc.), whether theinput is discrete (e.g. pressing of key) or continuous (e.g., a mouse'sposition, though digitized into a discrete quantity, is fast enough tobe considered continuous), the number of degrees of freedom involved(e.g., two-dimensional traditional mice, or three-dimensional navigatorsdesigned for CAD applications). Pointing devices (such as ‘computermouse’), which are input components used to specify a position in space,can further be classified according to whether the input is direct orindirect. With direct input, the input space coincides with the displayspace, i.e., pointing is done in the space where visual feedback or thepointer appears. Touchscreens and light pens involve direct input.Examples involving indirect input include the mouse and trackball, andwhether the positional information is absolute (e.g., on a touch screen)or relative (e.g., with a mouse that can be lifted and repositioned).Direct input is almost necessarily absolute, but indirect input may beeither absolute or relative. For example, digitizing graphics tabletsthat do not have an embedded screen involve indirect input and senseabsolute positions and are often run in an absolute input mode, but theymay also be set up to simulate a relative input mode like that of atouchpad, where the stylus or puck can be lifted and repositioned.Further, the input component 33 may include dedicated hard controls forfrequently used/accessed functions (e.g., repeat system message).

The indicator 37 may include a color display for displaying screenelements or for organizing on-screen items and controls for data entry.Further, the device may support the display of split-screen views. Manysystems used re-configurable keys/buttons whose function changedepending on the application. Typically, a switch is used to activatethe voice recognition system and it may increase system reliability. Theindicator 37 may provide auditory or visual feedback to confirm userinputs.

In one example, the sensor 32 may include a physiological sensor, formonitoring a live body such as a human body, for example the body of thetreated person 25. Such physiological sensor output may be used, as partof “Sensor Output” step 64 shown in FIG. 6 to adapt or optimize thedevice 31 operation to the person physiological condition or state.

The physiological sensor 32 may be used to sense, log and monitor vitalsigns, such as of patients suffering from chronic diseases such asdiabetes, asthma, and heart attack. The sensor may be ECG(Electrocardiography), involving interpretation of the electricalactivity of the heart over a period of time, as detected by electrodesattached to the outer surface of the skin. The sensor 32 may be used tomeasure oxygen saturation (SO2), involving the measuring the percentageof hemoglobin binding sites in the bloodstream occupied by oxygen. Apulse oximeter relies on the light absorption characteristics ofsaturated hemoglobin to give an indication of oxygen saturation. Venousoxygen saturation (SvO2) is measured to see how much oxygen the bodyconsumes, tissue oxygen saturation (StO2) can be measured by nearinfrared spectroscopy, and Saturation of peripheral oxygen (SpO2) is anestimation of the oxygen saturation level usually measured with a pulseoximeter device. Other sensors may be a blood pressure sensor, formeasuring is the pressure exerted by circulating blood upon the walls ofblood vessels, which is one of the principal vital signs, and may bebased on a sphygmomanometer measuring the arterial pressure. An EEG(Electroencephalography) sensor may be used for the monitoring ofelectrical activity along the scalp. EEG measures voltage fluctuationsresulting from ionic current flows within the neurons of the brain. Thesensors (or the sensor units) may be a small bio-sensor implanted insidethe human body, or may be worn at the human body, or as wearable, near,on or around a live body. Non-human applications may involve themonitoring of crops and animals. Such networks involving biologicalsensors may be part of a Body Area Network (BAN) or Body Sensor Network(BSN), and may be in accordance to, or based on, IEEE 802.15.6. Thesensor may be a biosensor, and may be according to, or based on, thesensor described in U.S. Pat. No. 6,329,160 to Schneider et al.,entitled: “Biosensors”, in U.S. Patent Application Publication No.2005/0247573 to Nakamura et al., entitled: “Biosensors”, in U.S. PatentApplication Publication No. 2007/0249063 to Deshong et al., entitled:“Biosensors”, or in U.S. Pat. No. 4,857,273 to Stewart, entitled:“Biosensors”, which are all incorporated in their entirety for allpurposes as if fully set forth herein.

Alternatively or in addition, the sensor 32 may be effective to ameasure of effective response of a user comprises, and/or is based on, aphysiological signal of the user, which reflects a physiological stateof the user, such as:

-   (a) Heart Rate (HR), Heart Rate Variability (HRV), and Blood-Volume    Pulse (BVP), and/or other parameters relating to blood flow, which    may be determined by various means such as electrocardiogram (ECG),    photoplethysmogram (PPG), and/or impedance cardiography (ICG).-   (b) Skin Conductance (SC), which may be measured via sensors for    Galvanic Skin Response (GSR), which may also be referred to as    Electrodermal Activity (EDA).-   (c) Skin Temperature (ST) may be measured, for example, with various    types of thermometers.-   (d) Brain activity and/or brainwave patterns, which may be measured    with electroencephalography (EEG), as described herein.-   (e) Brain activity determined based on functional magnetic resonance    imaging (fMRI).-   (f) Brain activity based on Magnetoencephalography (MEG).-   (g) Muscle activity, which may be determined via electrical signals    indicative of activity of muscles, e.g., measured with    electromyography (EMG). In one example, surface electromyography    (sEMG) may be used to measure muscle activity of frontalis and    corrugator supercilii muscles, indicative of eyebrow movement, and    from which an emotional state may be recognized.-   (h) Eye movement, e.g., measured with electrooculography (EOG).-   (i) Blood oxygen levels that may be measured using    hemoencephalography (HEG).-   (j) CO2 levels in the respiratory gases that may be measured using    capnography.-   (k) Concentration of various volatile compounds emitted from the    human body (referred to as the Volatome), which may be detected from    the analysis of exhaled respiratory gasses and/or secretions through    the skin using various detection tools that utilize nanosensors.-   (l) Temperature of various regions of the body and/or face may be    determined utilizing thermal Infra-Red (IR) cameras. For example,    thermal measurements of the nose and/or its surrounding region may    be utilized to estimate physiological signals such as respiratory    rate and/or occurrence of allergic reactions.

Alternatively or in addition, the sensor 32 may be an electric sensor orelectric meter 32 a that responds to an electrical characteristics orelectrical phenomenon quantity in an electrical circuit, and is used tomeasure electrical quantities or electrical properties. The electricalsensor 32 a may be connected in series or in parallel between thegenerator 35 and the electrodes 26 a and 26 b, to measure the burststrain signal 41 carried thereon. Such meter 32 a may be used as a safetymeasure to check that the power, current, voltage, or charge supplied orinserted to the human body via the electrodes 26 a and 26 b in withinpre-defined safe limits. Alternatively or in addition, this meter 32 aforms a closed control loop allowing the controller 39 to verify thatthe determined setting applied as part of an “Apply Settings” step 66are indeed provided. Further, the meter 32 a may be used to indicatewhether the electrodes are indeed attached to a person body. Forexample, measuring the current flowing via the electrodes may indicatethat the electrodes are not properly attached to the human body or thereis a short circuit.

The meter 32 a may be conductively coupled to the electrical circuit, ormay be a non-contact sensor non-conductively to the electrical circuit.The electrical sensor may be responsive to Alternating Current (AC) orDirect Current (DC). The electrical sensor may be an ampermeter thatresponds to electrical current passing through a conductor or wire, andmay consist of, or may comprise, a galvanometer, a hot-wire ampermeter,a current clamp, or a current probe. Alternatively or in addition, theelectrical sensor may be a voltmeter that responds to an electricalvoltage, and may consist of, or may comprise, an electrometer, aresistor, a potentiometer, or a bridge circuit. Alternatively or inaddition, the electrical sensor may be a wattmeter that responds toactive electrical power.

The electrical sensor 32 a may be conductively connected to the measuredelement. Alternatively or in addition, the electrical sensor may usenon-conductive or non-contact coupling to the measured element, such asmeasuring a phenomenon associated with the measured quantity orproperty. The electric sensor may be a current sensor or an ampmeter(a.k.a. ampermeter) for measuring DC or AC (or any other waveform)electric current passing through a conductor or wire. The current sensormay be connected such that part or entire of the measured electriccurrent may be passing through the ampermeter, such as a galvanometer ora hot-wire ampermeter. An ampermeter may be a current clamp or currentprobe, and may use the ‘Hall effect’ or a current transformer conceptfor non-contact or non-conductive current measurement. The electricalsensor may be a voltmeter for measuring the DC or AC (or any otherwaveform) voltage, or any potential difference between two points. Thevoltmeter may be based on the current passing a resistor using the Ohm'slaw, may be based on a potentiometer, or may be based on a bridgecircuit. The sensor 32 a may be a wattmeter measuring the magnitude ofthe active AC or DC power (or the supply rate of electrical energy). Thewattmeter may be a bolometer, used for measuring the power of incidentelectromagnetic radiation via the heating of a material with atemperature-dependent electrical resistance. The electrical sensor 32 amay be an ohmmeter for measuring the electrical resistance (orconductance), and may be a megohmmeter or a microohmeter. The ohmmetermay use the Ohm's law to derive the resistance from voltage and currentmeasurements, or may use a bridge such as a Wheatstone bridge. A sensormay be a capacitance meter for measuring capacitance. A sensor may be aninductance meter for measuring inductance. The sensor 32 a may be animpedance meter for measuring an impedance of a device or a circuit. Asensor may be an LCR meter, used to measure inductance (L), capacitance(C), and resistance (R). A meter may use sourcing a DC or an AC voltage,and use the ratio of the measured voltage and current (and their phasedifference) through the tested device according to Ohm's law tocalculate the resistance, the capacitance, the inductance, or theimpedance (R=V/I). Alternatively or in addition, a meter may use abridge circuit (such as Wheatstone bridge), where variable calibratedelements are adjusted to detect a null. The measurement may be using DC,using a single frequency or over a range of frequencies.

The sensor 32 a may be used to measure electrical quantities. Anelectrical sensor may be conductively connected to measure theelectrical parameter, or may be non-conductively coupled to measure anelectric-related phenomenon, such as magnetic field or heat. Further,the average or RMS value may be measured. An ampermeter (a.k.a. ammeter)is a current sensor that measures the magnitude of the electric currentin a circuit or in a conductor such as a wire. Electric current iscommonly measured in Amperes, milliampers, microamperes, or kiloampers.The sensor may be an integrating ammeter (a.k.a. watt-hour meter) wherethe current is summed over time, providing a current/time product, whichis proportional to the energy transferred. The measured electric currentmay be an Alternating Current (AC) such as a sinewave, a Direct Current(DC), or an arbitrary waveform. A galvanometer is a type of ampermeterfor detecting or measuring low current, typically by producing a rotarydeflection of a coil in a magnetic field. Some ampermeters use aresistor (shunt), whose voltage is directly proportional to the currentflowing through, requiring the current to pass through the meter. Ahot-wire ampermeter involves passing the current through a wire whichexpands as it heats, and the expansion is measured. A non-conductive ornon-contact current sensor may be based on ‘Hall effect’ magnetic fieldsensor, measuring the magnetic field generated by the current to bemeasured. Other non-conductive current sensors involve a current clampor current probe, which has two jaws which open to allow clamping aroundan electrical conductor, allowing for measuring of the electric currentproperties (commonly AC), without making a physical contact ordisconnecting the circuit. Such current clamp commonly comprises a wirecoil wounded around a split ferrite ring, acting as the secondarywinding of a current transformer, with the current-carrying conductoracting as the primary winding. Other current sensors and relatedcircuits are described in Zetex Semiconductors PLC application note“AN39—Current measurement application handbook” Issue 5, January 2008,which is incorporated in its entirety for all purposes as if fully setforth herein.

The sensor 32 a may be a voltmeter, commonly used for measuring themagnitude of the electric potential difference between two points.Electric voltage is commonly measured in volts, millivolts, microvolts,or kilovolts. The measured electric voltage may be an AlternatingCurrent (AC) such as a sinewave, a Direct Current (DC), or an arbitrarywaveform. Similarly, an electrometer may be used for measuring electriccharge (commonly in Coulomb units—C) or electrical potential difference,with very low leakage current. The voltmeter commonly works by measuringthe current through a fixed resistor, which, according to Ohm's Law, isproportional to the voltage across the resistor. A potentiometer-basedvoltmeter works by balancing the unknown voltage against a known voltagein a bridge circuit. A multimeter (a.k.a. VOM—Volt-Ohm-Millimeter) aswell as Digital MultiMeter (DMM), typically includes a voltmeter, anampermeter and an ohmmeter.

The sensor 32 a may be a wattmeter measuring the magnitude of the activepower (or the supply rate of electrical energy), commonly using watts(W), milliwatts, kilowatts, or megawatts units. A wattmeter may be basedon measuring the voltage and the current, and multiplying to calculatethe power P=VI. In AC measurement, the true power is P=VI cos(ϕ). Thewattmeter may be a bolometer, used for measuring the power of incidentelectromagnetic radiation via the heating of a material with atemperature-dependent electrical resistance. A sensor may be anelectricity meter (or electrical energy meter) that measures the amountof electrical energy consumed by a load. Commonly, an electricity meteris used to measure the energy consumed by a single load, an appliance, aresidence, a business, or any electrically powered device, and mayprovide or be the basis for the electricity cost or billing. Theelectricity meter may be an AC (single or multi-phase) or DC type, andthe common unit of measurement is kilowatt-hour, however any energyrelated unit may be used such as Joules. Some electricity meters arebased on wattmeters which accumulate or average the readings, or may bebased on induction.

The sensor 32 a may be an ohmmeter measuring the electrical resistance,commonly measured in ohms (Ω), milliohms, kiloohms or megohms, orconductance measured in Siemens (S) units. Low-resistance measurementscommonly use micro-ohmmeter, while megohmmeter (a.k.a. Megger) measureslarge value of resistance. Common ohmmeter passes a constant knowncurrent through the measured unknown resistance (or conductance), whilemeasuring the voltage across the resistance, and deriving the resistance(or conductance) value from Ohm's law (R=V/I). A Wheatstone bridge mayalso be used as a resistance sensor, by balancing two legs of a bridgecircuit, where one leg includes the unknown resistance (or conductance)component. Variations of Wheatstone bridge may be used to measurecapacitance, inductance, impedance and other electrical ornon-electrical quantities.

The sensor 32 a may be a capacitance meter for measuring capacitance,commonly using units of picofarads, nanofarads, microfarads, and Farads(F). A sensor may be an inductance meter for measuring inductance,commonly using SI units of Henry (H), such as microHenry, milliHenry,and Henry. Further, a sensor may be an impedance meter for measuring animpedance of a device or a circuit. The sensor 32 a may be an LCR meter,used to measure inductance (L), capacitance (C), and resistance (R). Ameter may use sourcing an AC voltage, and use the ratio of the measuredvoltage and current (and their phase difference) through the testeddevice according to Ohm's law to calculate the impedance. Alternativelyor in addition, a meter may use a bridge circuit (Similar to Wheatstonebridge concept), where variable calibrated elements are adjusted todetect a null. The measurement may be in a single frequency or over arange of frequencies.

The electrical sensor 32 a may be a magnetometer for measuring a local Hor B magnetic fields. The B-field (a.k.a. magnetic flux density ormagnetic induction) is measured in Tesla (T) in SI units and Gauss incgs units, and magnetic flux is measured in Weber (Wb) units. TheH-field (a.k.a. magnetic field intensity or magnetic field strength) ismeasured in ampere-turn per meter (A/m) in SI units, and in Oersteds(Oe) in cgs units. Many Smartphones contain magnetometers serving ascompasses. A magnetometer may be a scalar magnetometer, measuring thetotal strength, or may be a vector magnetometer, providing bothmagnitude and direction (relative to the spatial orientation) of themagnetic field. Common magnetometers include Hall effect sensor,magneto-diode, magneto-transistor, AMR magnetometer, GMR magnetometer,magnetic tunnel junction magnetometer, magneto-optical sensor, Lorentzforce based MEMS sensor (a.k.a. Nuclear Magnetic Resonance—NMR),Electron Tunneling based MEMS sensor, MEMS compasses, Nuclear precessionmagnetic field sensor, optically pumped magnetic field sensor, fluxgatemagnetometer, search coil magnetic field sensor, and SuperconductingQuantum Interference Device (SQUID) magnetometer. ‘Hall effect’magnetometers are based on ‘Hall probe’, which contains an indiumcompound semiconductor crystal such as indium antimonide, mounted on analuminum backing plate, and provides a voltage a voltage in response tothe measured B-field. A fluxgate magnetometer makes use of thenon-linear magnetic characteristics of a probe or sensing element thathas a ferromagnetic core. NMR and Proton Precession Magnetometers (PPM)measure the resonance frequency of protons in the magnetic field to bemeasured. SQUID meters are very sensitive vector magnetometers, based onsuperconducting loops containing Josephson junctions. The magnetometermay be Lorentz-force-based MEMS sensor, relying on the mechanical motionof the MEMS structure due to the Lorentz force acting on thecurrent-carrying conductor in the magnetic field.

Alternatively or in addition, the sensor 32 may be a blink detector,thus forming a closed control loop allowing the controller 39 to verifythat the determined settings applied as part of the “Apply Settings”step 66 are indeed provided and the required blinking rate or closure isindeed achieved. Further, such sensor 32 may be used to indicate whetherthe electrodes are indeed properly attached to a person body and thesystem functions properly. Any sensor herein may be used for detectingeye blinking or as part of a blink sensor or detector.

Accidents due to drowsiness can be controlled and prevented with thehelp of eye blink sensor using IR rays, as described in an articleentitled: “A Microcontroller Based Car-Safety System: ImplementingDrowsiness Detection And Vehicle-Vehicle Distance Detection In Parallel”by Pragyaditya Das. and S. Pragadeesh, published 2015 in INTERNATIONALJOURNAL OF SCIENTIFIC & TECHNOLOGY RESEARCH VOLUME 4, ISSUE 12, DECEMBER2015 ISSN 2277-8616 161 IJSTR©2015, which is incorporated in itsentirety for all purposes as if fully set forth herein. It consists ofIR transmitter and an IR receiver. The transmitter transmits IR raysinto the eye. If the eye is shut, then the output is high. If the eye isopen, then the output is low. This output is interfaced with an alarminside and outside the vehicle. This module can be connected to thebraking system of the vehicle and can be used to reduce the speed of thevehicle. The alarm inside the vehicle will go on for a period of timeuntil the driver is back to his senses. If the driver is unable to takecontrol of the vehicle after that stipulated amount of time, then thealarm outside the vehicle will go on to warn and tell others to help thedriver.

Facial paralysis remains one of the most challenging conditions toeffectively manage, often causing life-altering deficits in bothfunction and appearance. Facial rehabilitation via pacing and robotictechnology has great yet unmet potential. A critical first step towardsreanimating symmetrical facial movement in cases of unilateral paralysisis the detection of healthy movement to use as a trigger for stimulatedmovement. Testing a blink detection system that can be attached tostandard eyeglasses and used as part of a closed-loop facial pacingsystem is described in a paper entitled: “INFRARED-BASED BLINK DETECTINGGLASSES FOR FACIAL PACING: TOWARDS A BIONIC BLINK” by Alice Frigerio,Tessa A. Hadlock, Elizabeth H Murray, and James T Heaton, published 2014[JAMA Facial Plast Surg. 2014; 16(3): 211-218.doi:10.1001/jamafacial.2014.1], which is incorporated in its entiretyfor all purposes as if fully set forth herein. Standard safety glasseswere equipped with an infrared (IR) emitter/detector pair orientedhorizontally across the palpebral fissure, creating a monitored IR beamthat became interrupted when the eyelids closed.

A real-time online prototype driver-fatigue monitor is described in apaper entitled: “Accident Prevention Using Eye Blinking and HeadMovement” by Abhi R. Varma , Seema V. Arote, Chetna Bharti, and KuldeepSingh (all of Pravara Rural Engineering College, Loni). Published 2012in “Emerging Trends in Computer Science and InformationTechnology—2012(ETCSIT2012) Proceedings published in InternationalJournal of Computer Applications (IJCA)”, which is incorporated in itsentirety for all purposes as if fully set forth herein. It uses remotelylocated charge-coupled-device cameras equipped with active infraredilluminators to acquire video images of the driver. Various visual cuesthat typically characterize the level of alertness of a person areextracted in real time and systematically combined to infer the fatiguelevel of the driver. The visual cues employed characterize eyelidmovement, gaze movement, head movement, and facial expression. Aprobabilistic model is developed to model human fatigue and to predictfatigue based on the visual cues obtained. The simultaneous use ofmultiple visual cues and their systematic combination yields a much morerobust and accurate fatigue characterization than using a single visualcue. This system was validated under real-life fatigue conditions withhuman subjects of different ethnic backgrounds, genders, and ages;with/without glasses; and under different illumination conditions. Itwas found to be reasonably robust, reliable, and accurate in fatiguecharacterization.

In one example, the sensor 32 may include an environment sensor, formonitoring the environment in, or around, the device 31. Such sensoroutput may be used, as part of “Sensor Output” step 64 to adapt oroptimize the device 31 operation to the environmental condition. Forexample, in case of high temperature or low humidity, the blinking ratemay be increased to better water the eye.

An appropriate sensor 32 may be adapted for a specific physicalphenomenon, such as a sensor responsive to temperature, humidity,pressure, audio, vibration, light, motion, sound, proximity, flow rate,electrical voltage, and electrical current. The sensor 32 may bethermoelectric sensor, for measuring, sensing or detecting thetemperature (or the temperature gradient) of an object, which may besolid, liquid or gas. Such sensor may be a thermistor (either PTC orNTC), a thermocouple, a quartz thermometer, or an RTD. The sensor 32 maybe based on a Geiger counter for detecting and measuring radioactivityor any other nuclear radiation. Light, photons, or other opticalphenomena may be measured or detected by a photosensor or photodetector,used for measuring the intensity of visible or invisible light (such asinfrared, ultraviolet, X-ray or gamma rays). A photosensor may be basedon the photoelectric or the photovoltaic effect, such as a photodiode, aphototransistor, solar cell or a photomultiplier tube. A photosensor maybe a photoresistor based on photoconductivity, or a CCD where a chargeis affected by the light.

The sensor 32 may be an image sensor for providing digital camerafunctionality, allowing an image (either as still images or as a video)to be captured, stored, manipulated and displayed. The image capturinghardware integrated with the sensor unit may contain a photographic lens(through a lens opening) focusing the required image onto aphotosensitive image sensor array disposed approximately at an imagefocal point plane of the optical lens, for capturing the image andproducing electronic image information representing the image. The imagesensor may be based on Charge-Coupled Devices (CCD) or ComplementaryMetal-Oxide-Semiconductor (CMOS). The image may be converted into adigital format by an image sensor AFE (Analog Front End) and an imageprocessor, commonly including an analog to digital (A/D) convertercoupled to the image sensor for generating a digital data representationof the image. The unit may contain a video compressor, coupled betweenthe analog to digital (A/D) converter and the transmitter forcompressing the digital data video before transmission to thecommunication medium. The compressor may be used for lossy or non-lossycompression of the image information, for reducing the memory size andreducing the data rate required for the transmission over thecommunication medium. The compression may be based on a standardcompression algorithm such as JPEG (Joint Photographic Experts Group)and MPEG (Moving Picture Experts Group), ITU-T H.261, ITU-T H.263, ITU-TH.264, or ITU-T COR 601.

The sensor 32 may be a strain gauge, used to measure the strain, or anyother deformation, of an object. The sensor may be based on deforming ametallic foil, semiconductor strain gauge (such as piezoresistors),measuring the strain along an optical fiber, capacitive strain gauge,and vibrating or resonating of a tensioned wire. Any sensor herein maybe a tactile sensor, being sensitive to force or pressure, or beingsensitive to a touch by an object, typically a human touch. A tactilesensor may be based on a conductive rubber, a lead zirconate titanate(PZT) material, a polyvinylidene fluoride (PVDF) material, a metalliccapacitive element, or any combination thereof. A tactile sensor may bea tactile switch, which may be based on the human body conductance,using measurement of conductance or capacitance.

The sensor 32 may be a piezoelectric sensor, where the piezoelectriceffect is used to measure pressure, acceleration, strain or force, andmay use transverse, longitudinal, or shear effect mode. A thin membranemay be used to transfer and measure pressure, while mass may be used foracceleration measurement. A piezoelectric sensor element material may bea piezoelectric ceramics (such as PZT ceramic) or a single crystalmaterial. A single crystal material may be gallium phosphate, quartz,tourmaline, or Lead Magnesium Niobate-Lead Titanate (PMN-PT).

The sensor 32 may be a motion sensor, and may include one or moreaccelerometers, which measures the absolute acceleration or theacceleration relative to freefall. The accelerometer may bepiezoelectric, piezoresistive, capacitive, MEMS or electromechanicalswitch accelerometer, measuring the magnitude and the direction thedevice acceleration in a single-axis, 2-axis or 3-axis(omnidirectional). Alternatively or in addition, the motion sensor maybe based on electrical tilt and vibration switch or any otherelectromechanical switch.

The sensor 32 may be a force sensor, a load cell, or a force gauge(a.k.a. force gage), used to measure a force magnitude and/or direction,and may be based on a spring extension, a strain gauge deformation, apiezoelectric effect, or a vibrating wire. Any sensor herein may be adriving or passive dynamometer, used to measure torque or any moment offorce.

Any sensor herein may be a pressure sensor (a.k.a. pressure transduceror pressure transmitter/sender) for measuring a pressure of gases orliquids, and for indirectly measuring other parameters such as fluid/gasflow, speed, water-level, and altitude. A pressure sensor may be apressure switch. A pressure sensor may be an absolute pressure sensor, agauge pressure sensor, a vacuum pressure sensor, a differential pressuresensor, or a sealed pressure sensor. The changes in pressure relative toaltitude may be used for an altimeter, and the Venturi effect may beused to measure flow by a pressure sensor. Similarly, the depth of asubmerged body or the fluid level on contents in a tank may be measuredby a pressure sensor.

A pressure sensor may be of a force collector type, where a forcecollector (such a diaphragm, piston, bourdon tube, or bellows) is usedto measure strain (or deflection) due to applied force (pressure) overan area. Such sensor may be a based on the piezoelectric effect (apiezoresistive strain gauge), may be of a capacitive or of anelectromagnetic type. A pressure sensor may be based on a potentiometer,or may be based on using the changes in resonant frequency or thethermal conductivity of a gas, or may use the changes in the flow ofcharged gas particles (ions).

The sensor 32 may be a position sensor for measuring linear or angularposition (or motion). A position sensor may be an absolute positionsensor, or may be a displacement (relative or incremental) sensor,measuring a relative position, and may be an electromechanical sensor. Aposition sensor may be mechanically attached to the measured object, oralternatively may use a non-contact measurement.

A position sensor may be an angular position sensor, for measuringinvolving an angular position (or the rotation or motion) of a shaft, anaxle, or a disk. Absolute angular position sensor output indicates thecurrent position (angle) of the shaft, while incremental or displacementsensor provides information about the change, the angular speed or themotion of the shaft. An angular position sensor may be of optical type,using reflective or interruption schemes, or may be of magnetic type,such as based on variable-reluctance (VR), Eddy-current killedoscillator (ECKO), Wiegand sensing, or Hall-effect sensing, or may bebased on a rotary potentiometer. An angular position sensor may betransformer based such as a RVDT, a resolver or a synchro. An angularposition sensor may be based on an absolute or incremental rotaryencoder, and may be a mechanical or optical rotary encoder, using binaryor gray encoding schemes.

The sensor 32 may be a mechanical or electrical motion detector (or anoccupancy sensor), for discrete (on/off) or magnitude-based motiondetection. A motion detector may be based on sound (acoustic sensors),opacity (optical and infrared sensors and video image processors),geomagnetism (magnetic sensors, magnetometers), reflection oftransmitted energy (infrared laser radar, ultrasonic sensors, andmicrowave radar sensors), electromagnetic induction (inductive-loopdetectors), or vibration (triboelectric, seismic, and inertia-switchsensors). Acoustic sensors may use electric effect, inductive coupling,capacitive coupling, triboelectric effect, piezoelectric effect, fiberoptic transmission, or radar intrusion sensing. An occupancy sensor istypically a motion detector that may be integrated with hardware orsoftware-based timing device.

A motion sensor may be a mechanically-actuated switch or trigger, or mayuse passive or active electronic sensors, such as passive infraredsensors, ultrasonic sensors, microwave sensor or tomographic detector.Alternatively or in addition, motion can be electronically identifiedusing infrared (PIR) or laser optical detection or acoustical detection,or may use a combination of the technologies disclosed herein.

The sensor 32 may be a humidity sensor, such as a hygrometer or ahumidistat, and may respond to an absolute, relative, or specifichumidity. The measurement may be based on optically detectingcondensation, or may be based on changing the capacitance, resistance,or thermal conductivity of materials subjected to the measured humidity.

The sensor 32 may be a clinometer for measuring angle (such as pitch orroll) of an object, typically with respect to a plane such as the earthground plane. A clinometer may be based on an accelerometer, a pendulum,or on a gas bubble in liquid, or may be a tilt switch such as a mercurytilt switch for detecting inclination or declination with respect to adetermined tilt angle.

The sensor 32 may be a gas or liquid flow sensor, for measuring thevolumetric or mass flow rate via a defined area or a surface. A liquidflow sensor typically involves measuring the flow in a pipe or in anopen conduit. A flow measurement may be based on a mechanical flowmeter, such as a turbine flow meter, a Woltmann meter, a single jetmeter, or a paddle wheel meter. Pressure-based meters may be based onmeasuring a pressure or a pressure differential based on Bernoulli'sprinciple, such as a Venturi meter. The sensor may be an optical flowmeter or be based on the Doppler-effect.

A flow sensor may be an air flow sensor, for measuring the air or gasflow, such as through a surface (e.g., through a tube) or a volume, byactually measuring the air volume passing, or by measuring the actualspeed or air flow. In some cases, a pressure, typically differentialpressure, may be measured as an indicator for the air flow measurements.An anemometer is an air flow sensor primarily for measuring wind speed,and may be cup anemometer, a windmill anemometer, hot-wire anemometersuch as CCA (Constant-Current Anemometer), CVA (Constant-VoltageAnemometer) and CTA (Constant-Temperature Anemometer). Sonic anemometersuse ultrasonic sound waves to measure wind velocity. Air flow may bemeasured by a pressure anemometer that may be a plate or tube class.

The sensor 32 may be a gyroscope, for measuring orientation in space,such as the conventional mechanical type, a MEMS gyroscope, apiezoelectric gyroscope, a FOG, or a VSG type. A sensor may be ananosensor, a solid-state, or an ultrasonic based sensor. Any sensorherein may be an eddy-current sensor, where the measurement may be basedon producing and/or measuring eddy-currents. Sensor may be a proximitysensor, such as metal detector. Any sensor herein may be a bulk orsurface acoustic sensor, or may be an atmospheric sensor. While theapparatus and method herein are described involving deterministicoperation, the operation may be based on, or associated with, randomnessbased on random numbers. For example, using continuous and steadyblinking rate of the person 25, which corresponds to the period T 41 dof the bursts train 41, may be visualized as ‘mechanical’ or ‘robotic’behavior, in contrast to the normal variable blinking rate. As such, theperiod T 41 d of the bursts train 41 may be randomized, such as betweenminimum and maximum values, such as between 4 and 6 seconds, trying tomimic a normal blinking behavior.

In such a case, a stimulating device 31 b shown as part of anarrangement 40 a illustrated in FIG. 4a may comprise a random numbergenerator 48 for generating random numbers that may be hardware-basedusing thermal noise, shot noise, nuclear decaying radiation,photoelectric effect, or quantum phenomena. Alternatively or inaddition, the random number generator 48 may be software-based and mayexecute an algorithm for generating pseudo-random numbers.

In one example, during the period between consecutive bursts 41 a whenno energy is transmitted to the electrodes 26 a and 26 b, the electrodesare used for electrical measurement of the human body, such as formeasuring the impedance of the skin. Such a stimulator device 31 b isshown as part of an arrangement 40 b illustrated in FIG. 4b . ASingle-Pole-Double-Throw (SPDT) two-way switch 29 a is added between thesignal generator 42 and the electrodes 26 a and 26 b. The switch 29 a iscontrolled by the controller 39 via a port or connection 44 a. In onestate of the switch 29 a, shown as state ‘1’ of the switch, the cable orwires 38 b is connected to the signal generator 42 via the connection 38a, reverting to the operation is described in the arrangement 40 shownin FIG. 4 or as described in the arrangement 40 a shown in FIG. 4 a,where electric pulses or bursts are transmitted to the human body 25 viathe electrodes 26 a and 26 b. In another state of the switch 29 a, shownas state ‘2’ of the switch, the cable or wires 38 b is connected to animpedance meter 32 b for measuring an impedance of the human skin viathe electrodes 26 a and 26 b. The measurement result is output to thecontroller 39 to be used thereof. For example, the impedance measuringmay be performed during a period 41 e (during which the switch 29 a isin state ‘2’) between two consecutive bursts 41 a (during which theswitch 29 a is in state ‘1’) connecting the busts 41 a to the electrodes26 a and 26 b.

The impedance meter 32 b serves as an electrical sensor and may be anohmmeter measuring the electrical resistance, commonly measured in ohms(Ω), milliohms, kiloohms or megohms, or conductance measured in Siemens(S) units. Low-resistance measurements commonly use micro-ohmmeter,while megohmmeter (a.k.a. Megger) measures large value of resistance.Common ohmmeter passes a constant known current through the measuredunknown resistance (or conductance), while measuring the voltage acrossthe resistance, and deriving the resistance (or conductance) value fromOhm's law (R=V/I). A Wheatstone bridge may also be used as a resistancesensor, by balancing two legs of a bridge circuit, where one legincludes the unknown resistance (or conductance) component. Variationsof Wheatstone bridge may be used to measure capacitance, inductance,impedance, and other electrical or non-electrical quantities.

The electrical sensor 32 b may be a capacitance meter for measuringcapacitance, commonly using units of picofarads, nanofarads,microfarads, and Farads (F). The meter 32 b may be an inductance meterfor measuring inductance, commonly using SI units of Henry (H), such asmicroHenry, milliHenry, and Henry. Further, a sensor may be an impedancemeter for measuring an impedance of a device or a circuit. The sensor 32a may be an LCR meter, used to measure inductance (L), capacitance (C),and resistance (R). The meter 32 a may use sourcing an AC voltage, anduse the ratio of the measured voltage and current (and their phasedifference) through the tested device according to Ohm's law tocalculate the impedance. Alternatively or in addition, a meter may use abridge circuit (Similar to Wheatstone bridge concept), where variablecalibrated elements are adjusted to detect a null. The measurement maybe in a single frequency, or over a range of frequencies.

The output of the impedance meter 32 b, wither alone or in conjunctionwith other sensors, such as sensor 32, may be part of the “SensorOutput” step 64, and as such may be used to determine any of the devicesettings as part of the “Determine Settings” step 65, as describedabove, and as such may impact, change, or affect the device operation aspart of the “Apply Settings” step 66, such as any of the signal 41parameters, such as the burst duration ‘d’ 41 a, the repetition period‘T’ 41 b, the amplitude A 41 c, the burst internal frequency 41 d, r anycombination thereof. For example, a low resistance measured may indicatethat the person 25 is sweating, suggesting in physical action such aswalking or running, and increasing the blinking rate.

The impedance meter 32 b may use, may be based on, or may comprise, anyof the circuits or techniques described in an Application Note entitled:“Keysight Technologies—Impedance Measurement Handbook—A guide tomeasurement technology and techniques—6^(th) Edition”, published Nov. 2,2016 by Keysight Technologies, Inc. [5950-3000], which is incorporatedin its entirety for all purposes as if fully set forth herein.Alternatively or in addition, the impedance meter 32 b may use, may bebased on, or may comprise, any of the circuits or techniques describedin an Application Note AN-1302 Revision A entitled: “Optimizing theADuCM350 for 4-Wire, Bioisolated Impedance Measurement Applications”,published 2018 by Analog Devices, Inc. [AN12168-0-2/18(A)], which isincorporated in its entirety for all purposes as if fully set forthherein.

The device 31 operation may be according to a general flow chart 60shown in FIG. 6, as controlled by the controller 39. The controller 39may determine as part of a “Determine Settings” step 65, if thegenerator 35 may be activated or deactivated as part of a“Activate/Deactivate” step 68, such as by directly controlling thegenerator 35 or by an actuating or de-actuating the switch 29 by thecontrol port 45 via the connection 44. Alternatively or in addition, thecontroller 39 may set the bursts train 41 parameters as part of an“Apply Settings” step 66, such as via the control port of connection 47.The burst train parameters that may be set as part of the “ApplySettings” step 66 include the peak-to-peak amplitude ‘A’ 41 c (or thenominal value, or effective value, of the signal 41), the burst durationd 41 a, the frequency ‘f’ of the signal in the burst 41 d, and theperiod T 41 b. The activation as part of the “Activate/Deactivate” step68 or the settings of the bursts train 41 parameters as part of an“Apply Settings” step 66 may be determined, as part of the “DetermineSettings” step 65, in a deterministic way. Alternatively or in addition,the operation may involve randomness based on random number generated aspart of a “Random Number” step 67, which may use the random numbergenerator 48 shown as part of the device 31 b in the arrangement 40 a.

The device 31 may store “Default Setting” 63 that may include varioussettings that are used or assumed when no other input or command isavailable, such as upon power up before any other input or command isobtained or received. The activation (or deactivation) as part of the“Activate/Deactivate” step 68 or the settings of the bursts train 41parameters as part of an “Apply Settings” step 66 may be determined, aspart of the “Determine Settings” step 65, based on, or using, an inputfrom the user as part of a “User Input” step 61, which may use, or maybe based on, the user control 33 functionality. For example, a humanuser, such as the treated person 25, may activate the deice 31 when notneeded (e.g., while sleeping), or may adjust the amplitude A 41 c to alevel that minimize pain or discomfort. Alternatively or in addition,the activation (or deactivation) as part of the “Activate/Deactivate”step 68 or the settings of the bursts train 41 parameters as part of an“Apply Settings” step 66 may be determined, as part of the “DetermineSettings” step 65, based on, or using, an external command or inputreceived, as part of an “External Command” step 62, from an externalnetwork via the communication interface 36.

Alternatively or in addition, the activation (or deactivation) as partof the “Activate/Deactivate” step 68 or the settings of the bursts train41 parameters as part of an “Apply Settings” step 66 may be determined,as part of the “Determine Settings” step 65, based on, or using, thesensor 32 output, as part of a “Sensor Output” step 64. For example, theblinking rate (corresponding to the period T 41 b) maybe optimized tothe environment, such as higher blinking rate in case of highertemperature when the sensitivity to dry eye may be increased. In oneexample, a minimum or maximum threshold is defined associated with thesensor 32 output value, so that the device 31 is activated (ordeactivated) in case where the sensor output is below the minimumthreshold or is above the maximum threshold.

In one example, the controller 39 transmits over the external network,as part of a “External Status” step 69 using the communication interface36 the device 31 status, such as activating/deactivating status, powersource 34 (such as the battery 34 a) status, sensor value, settingsused, or any other information available in the device 31. Further, thedevice 31 status, such as activating/deactivating status, power source34 (such as the battery 34 a) status, sensor value, settings used, orany other information available in the device 31, may be indicated to ahuman user via the indicator 37.

As part of the “External Status” step 69, a message may be sent that mayinclude identification of the device 31, such as its IP address, thetime of sending the message, and the status. A notifying message may besent periodically, such as every 1, 2, 5, or 10 seconds, every 1, 2, 5,or 10 minutes, every 1, 2, 5, or 10 hours, or every 1, 2, 5, or 10 days.Alternatively or in addition, the user may be notified by using anevent-driven messaging. For example, a message may be transmitted upon achange in any parameter or characteristic in the device 31.Alternatively or in addition, a message may be transmitted upon thesensor 32 output exceeding a set maximum threshold, or upon measuring asensor output below a set minimum threshold. Further, a message may besent as a response to a received message, such as for acknowledgement.The message may be sent using XMPP, SIMPLE, Apple Push NotificationService (APNs), or IMPS. The message may be a text-based message, suchas by using SMS, or Twitter services, as well as social marketingservice such as Facebook. Alternatively or addition, the message mayinclude an audio or video message, and sent using MMS or EnhancedMessaging Service (EMS). Other services such as e-mail, Viber, orWhatsapp may be used.

The notification or data sent as part of “External Status” step 69 maybe text based, such as an electronic mail (e-mail), website content,fax, or a Short Message Service (SMS). Alternatively or in addition, thenotification or alert to the user device may be voice based, such as avoicemail, a voice message to a telephone device. Alternatively or inaddition, the notification or the data to the user device may activate avibrator, causing vibrations that are felt by human body touching, ormay be based on a Multimedia Message Service (MMS) or Instant Messaging(IM). The messaging, alerting, and notifications may be based on,include part of, or may be according to U.S. Patent Application No.2009/0024759 to McKibben et al. entitled: “System and Method forProviding Alerting Services”, U.S. Pat. No. 7,653,573 to Hayes, Jr. etal. entitled: “Customer Messaging Service”, U.S. Pat. No. 6,694,316 toLangseth. et al. entitled: “System and Method for a Subject-BasedChannel Distribution of Automatic, Real-Time Delivery of PersonalizedInformational and Transactional Data”, U.S. Pat. No. 7,334,001 toEichstaedt et al. entitled: “Method and System for Data Collection forAlert Delivery”, U.S. Pat. No. 7,136,482 to Wille entitled: “ProgressiveAlert Indications in a Communication Device”, U.S. Patent ApplicationNo. 2007/0214095 to Adams et al. entitled: “Monitoring and NotificationSystem and Method”, U.S. Patent Application No. 2008/0258913 to Buseyentitled: “Electronic Personal Alert System”, or U.S. Pat. No. 7,557,689to Seddigh et al. entitled: “Customer Messaging Service”, which are allincorporated in their entirety for all purposes as if fully set forthherein.

Major facial nerve branches outside of the skull is illustrated in aview 70 shown in FIG. 7. The point (X) in the illustration 70 ispointing the approximate location where the nerve extends outside of theskull, before branching to the different parts of the face. The facialnerve branches off to smaller nerves and muscles that go to 5 differentparts of the face. Therefore, when the nerve is damaged those smallerveins are not supplied with enough blood for circulation which isnecessary for muscles in the different areas of the face to move. Eachnerve branch affects the movement of different muscles. The TemporalBranch (Frontal Branch), marked ‘1’ in FIG. 7, affects the muscles inthe Forehead, and the Zygomatic Branch (Malar Branches), marked ‘2’ inFIG. 7, affects the Upper Cheek. The Temporal and the Zygomatic Branchtogether affect the muscles control opening and closure of the Eye. TheBuccal Branch (Infraorbital Branches), marked ‘3’ in FIG. 7, affects thecheek and above the mouth muscles, the Marginal Mandibular Branch,marked ‘4’ in FIG. 7, affects the chin muscles, and the Cervical Branch,marked ‘5’ in FIG. 7, affects some of the neck muscles. Facial nervedamage may affect the eyes, where the nerves from the Zygomatic Branchresults in eyelid problems. This nerve controls the ability or lackthereof to either; 1) Blinking, or 2) Tear Production, but it can alsocause 3) Ptosis (Droopy Eyelid). Dry eye can help as a warning of facialnerve damage. Other facial nerve damage may affect eating, since withoutthe ability to move the Buccal branch and the Marginal MandibularBranch, holding food in your mouth becomes very frustrating, andawkward. Drinking with a straw is often necessary. Similarly, talkingmay be affected since the same nerves that make eating difficult canalso make proper or clear pronunciation of certain letters/sounds; B, P,M, and W. Facial nerve damage may affect a Droopy Face, due to lack ofcomplete eyelid closure and a fallen smile, and nasal issues, such as arunny nose or congestion. Further, lack of control of wrinkled foreheadsymmetry, as well as saliva and tooth decay/dry mouth may be affected,since anything that diminishes the flow of saliva will dramaticallyincrease the incidence of tooth decay. Although medications thatstimulate Salivary Glands secretion are available, their side effects(nausea and diarrhea) often make them poorly tolerated. There are avariety of “artificial saliva” products that are available for purchaseover the counter. But there is no substitute for prescription-strengthtopical fluoride preparations, whether; 1) applied in the dental officewith fluoride varnishes, or 2) as prescription fluoride products forhome use.

An optimal location of electrodes for eliciting blinking would provideclosure of both lower and upper eye lid muscles, while using minimumcurrent (or energy) thus minimizing pain or discomfort. Preferably, boththe Zygomatic branch (for lower eye lid closure) and the Temporal branch(for higher eye lid closure) are stimulated, providing maximum or fullclosure of the eye when blinking is stimulated. Similarly, other bundleof nerves may be stimulated, simultaneously triggering few nerves thatcooperate to form an action. Conventional locating of electrodesinvolves horizontal locating of the electrodes. However, variousexperiments suggest that such optimal location is locating a firstelectrode 26 b near the Temporal Branch close to, and above, the eye,while the other electrode 26 a is located near the Zygomatic branchsplit point, close to, and below, the eye, as shown in the illustration70.

An example of locating electrodes is shown in a view 70 a shown in FIG.7a . As a reference, measurements use an imaginary line 73 which is theshortest line connecting the eye (where blinking is to be felicitated)and the ear of the same face side (either right eye and right ear, orleft eye and left ear). The center of the conductive area of theelectrode 26 b is assumed to be point 71 b, and the center of theconductive area of the electrode 26 a is assumed to be point 71 a.Preferably, part of, most of, or all of, the conductive area of theelectrode 26 b may be above the imaginary line 73. Similarly, preferablypart of, most of, or all of, the conductive area of the electrode 26 amay be below the imaginary line 73.

The center point 71 b of the conductive area of the electrode 26 b maybe at a distance 74 b above the imaginary line 73. The distance 74 b maybe at least 1 millimeter (mm), 2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, or 100 mm. Alternativelyor in addition, the distance 74b may be less than 2 millimeter (mm), 3mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm,70 mm, 100 mm, or 120 mm. Similarly, the center point 71 a of theconductive area of the electrode 26 a may be at a distance 74 a abovethe imaginary line 73. The distance 74 a may be at least 1 millimeter(mm), 2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm,40 mm, 50 mm, 70 mm, or 100 mm. Alternatively or in addition, thedistance 74 a may be less than 2 millimeter (mm), 3 mm, 5 mm, 7 mm, 10mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, 100 mm, or120 mm.

In one example, the center points 71 a and 71 b may be along a same linethat is perpendicular to the imaginary line 73. Alternatively or inaddition, the center point 71 a may be along a line 72 a that isperpendicular to the imaginary line 73, while the center point 71 b maybe along a different line 72 b that is perpendicular to the imaginaryline 73. In one example, a line 74 may be in the middle of the two lines72 a and 72 b. The centers of the electrodes may be at a distance 75(measured between the closest points along the imaginary line 73) asshown in the illustration 70 a in FIG. 7a . The distance 75 may be atleast 0 mm, 1 millimeter (mm), 2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, 70 mm, or 100 mm. Alternativelyor in addition, the distance 75 may be less than 1 millimeter (mm), 2mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm,50 mm, 70 mm, 100 mm, or 120 mm.

The term ‘center’ of an electrode herein refers to a centerpointrelating to the conductive area of the electrode that is touching, or isconfigured or designed to touch, the skin of a person, where everystraight line in the area that goes through this point equally dividesthe area into two equal areas. In a case of circular shaped electrodes,the circle center is the center point.

Any device herein, such as the device 31 shown in FIG. 3, may beaddressable in a network or the Internet using a digital address thatmay be a MAC layer address that may be MAC-48, EUI-48, or EUI-64 addresstype. Alternatively or in addition, the digital address may be a layer 3address and may be static or dynamic IP address that may be IPv4 or IPv6type address.

The device 31 may communicate over a network using the communicationinterface 36. In one example, the network is a wireless network thatuses an antenna 46 and a wireless transceiver 43, which may part of thedevice 31 a as shown in FIG. 4. In one example, as shown for the device31 b in the arrangement 40 a, the wireless networking is used forcommunication with a smartphone 49. The wireless network may be aWireless Wide Area Network (WWAN), such as WiMAX network or a cellulartelephone network (such as Third Generation (3G) or Fourth Generation(4G) network). Alternatively or in addition, the wireless network may bea BAN (Body Area Network) or Wireless Personal Area Network (WPAN) thatmay be according to, may be compatible with, or may be based on,Bluetooth™ or IEEE 802.15.1-2005 standards, or may be according to, ormay be based on, ZigBee™, IEEE 802.15.4-2003, or Z-Wave™ standard.Alternatively or in addition, the wireless network may be a WirelessLocal Area Network (WLAN) that may be according to, may be compatiblewith, or may be based on, IEEE 802.11-2012, IEEE 802.11a, IEEE 802.11b,IEEE 802.11g, IEEE 802.11n, or IEEE 802.11ac.

Further, any device herein, such as the device 31 a shown in FIG. 4, maybe operative to communicate in an ad-hok scheme or for use with anintermediary device, where the wireless transceiver may be operative tocommunicate with the intermediary device using an infrastructure scheme.The intermediary device may be a Wireless Access Point (WAP), a wirelessswitch, or a wireless router. The wireless transceiver may be operativeto wirelessly communicate and a wireless device, such as a hand-held orportable wireless device that may consist of, or comprise, a PersonalDigital Assistant (PDA), a tablet computer, or a smartphone.

The Device

The device 31 may serve as a client device and may access data, such asretrieving data from, or sending data to, over the Internet. In the caseof wireless networking, the wireless network may use any type ofmodulation, such as Amplitude Modulation (AM), a Frequency Modulation(FM), or a Phase Modulation (PM). Further, the wireless network may be acontrol network (such as ZigBee or Z-Wave), a home network, a WPAN(Wireless Personal Area Network), a WLAN (wireless Local Area Network),a WWAN (Wireless Wide Area Network), or a cellular network. An exampleof a Bluetooth-based wireless controller that may be included in awireless transceiver is SPBT2632C1A Bluetooth module available fromSTMicroelectronics NV and described in the data sheet Doc1D022930 Rev. 6dated April 2015 entitled: “SPBT2632C1A—Bluetooth® technology class-1module”, which is incorporated in its entirety for all purposes as iffully set forth herein.

Some embodiments may be used in conjunction with one or more types ofwireless communication signals and/or systems, for example, RadioFrequency (RF), Infra-Red (IR), Frequency-Division Multiplexing (FDM),Orthogonal FDM (OFDM), Time-Division Multiplexing (TDM), Time-DivisionMultiple Access (TDMA), Extended TDMA (E-TDMA), General Packet RadioService (GPRS), extended GPRS, Code-Division Multiple Access (CDMA),Wideband CDMA (WCDMA), CDMA 2000, single-carrier CDMA, multi-carrierCDMA, Multi-Carrier Modulation (MDM), Discrete Multi-Tone (DMT),Bluetooth (RTM), Global Positioning System (GPS), Wi-Fi, Wi-Max, ZigBee(TM), Ultra-Wideband (UWB), Global System for Mobile communication(GSM), 2G, 2.5G, 3G, 3.5G, Enhanced Data rates for GSM Evolution (EDGE),or the like. Further, a wireless communication may be based on, or maybe compatible with, wireless technologies that are described in Chapter20: “Wireless Technologies” of the publication number 1-587005-001-3 byCisco Systems, Inc. (July 1999) entitled: “Internetworking TechnologiesHandbook”, which is incorporated in its entirety for all purposes as iffully set forth herein.

Alternatively or in addition, the networking or the communication withthe of the over the wireless network may be using, may be according to,may be compatible with, or may be based on, Near Field Communication(NFC) using passive or active communication mode, and may use the 13.56MHz frequency band, and data rate may be 106 Kb/s, 212 Kb/s, or 424Kb/s, and the modulation may be Amplitude-Shift-Keying (ASK), and may beaccording to, may be compatible with, or based on, ISO/IEC 18092,ECMA-340, ISO/IEC 21481, or ECMA-352. In such a case, the wirelesstransceiver 43 may be an NFC transceiver and the respective antenna 46may be an NFC antenna.

Alternatively or in addition, the networking or the communication withthe of the wireless-capable device 31 a over the wireless network may beusing, may be according to, may be compatible with, or may be based on,a Wireless Personal Area Network (WPAN) that may be according to, may becompatible with, or based on, Bluetooth™ or IEEE 802.15.1-2005standards, and the wireless transceiver 43 may be a WPAN modem, and therespective antenna 46 may be a WPAN antenna. The WPAN may be a wirelesscontrol network according to, may be compatible with, or based on,ZigBee™ or Z-Wave™ standards, such as IEEE 802.15.4-2003.

Alternatively or in addition, the networking or the communication withthe of the wireless-capable device 31 a over the wireless network may beusing, may be according to, may be compatible with, or may be based on,a Wireless Local Area Network (WLAN) that may be according to, may becompatible with, or based on, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g,IEEE 802.11n, or IEEE 802.11ac standards, and the wireless transceiver43 may be a WLAN modem, and the respective antenna 46 may be a WLANantenna.

Alternatively or in addition, the networking or the communication withthe of the wireless-capable device 31 a over the wireless network may beusing, may be according to, may be compatible with, or may be based on,a wireless broadband network or a Wireless Wide Area Network (WWAN), andthe wireless transceiver 43 may be a WWAN modem, and the respectiveantenna 46 may be a WWAN antenna. The WWAN may be a WiMAX network suchas according to, may be compatible with, or based on, IEEE 802.16-2009,and the wireless transceiver 43 may be a WiMAX modem, and the respectiveantenna 46 may be a WiMAX antenna. Alternatively or in addition, theWWAN may be a cellular telephone network and the wireless transceiver 43may be a cellular modem, and the respective antenna 46 may be a cellularantenna. The WWAN may be a Third Generation (3G) network and may useUMTS W-CDMA, UMTS HSPA, UMTS TDD, CDMA2000 1xRTT, CDMA2000 EV-DO, or GSMEDGE-Evolution. The cellular telephone network may be a FourthGeneration (4G) network and may use HSPA+, Mobile WiMAX, LTE,LTE-Advanced, MBWA, or may be based on, or may be compatible with, IEEE802.20-2008.

Alternatively or in addition, the networking or the communication withthe of the wireless-capable device 31 a over the wireless network may beusing, may be according to, may be compatible with, or may be based on,a licensed or an unlicensed radio frequency band, such as theIndustrial, Scientific and Medical (ISM) radio band.

The sensor 32 provides an electrical output signal in response to aphysical, chemical, biological or any other phenomenon, serving as astimulus to the sensor. The sensor may serve as, or be, a detector, fordetecting the presence of the phenomenon. Alternatively or in addition,a sensor may measure (or respond to) a parameter of a phenomenon or amagnitude of the physical quantity thereof. For example, the sensor 32may be a thermistor or a platinum resistance temperature detector, alight sensor, a pH probe, or a piezoelectric bridge. Similarly, thesensor 32 may be used to measure pressure, flow, force or othermechanical quantities. A signal conditioning circuit is typicallycoupled to the sensor 32 output, for adapting and preparing the outputsignal for further processing. For example, the conditioning circuit mayinclude an amplifier connected to the sensor output. Other signalconditioning may also be applied in order to improve the handling of thesensor output or adapting it to the next stage or manipulating, such asattenuation, delay, current or voltage limiting, level translation,galvanic isolation, impedance transformation, linearization,calibration, filtering, amplifying, digitizing, integration, derivation,and any other signal manipulation. Some sensors conditioning involvesconnecting them in a bridge circuit. In the case of conditioning, theconditioning circuit may added to manipulate the sensor output, such asfilter or equalizer for frequency related manipulation such asfiltering, spectrum analysis or noise removal, smoothing or de-blurringin case of image enhancement, a compressor (or de-compressor) or coder(or decoder) in the case of a compression or a coding/decoding schemes,modulator or demodulator in case of modulation, and extractor forextracting or detecting a feature or parameter such as patternrecognition or correlation analysis. In case of filtering, passive,active or adaptive (such as Wiener or Kalman) filters may be used. Theconditioning circuits may apply linear or non-linear manipulations.Further, the manipulation may be time-related such as analog or digitaldelay-lines, integrators, or rate-based manipulation. A sensor 32 mayhave analog output, requiring an A/D to be connected thereto, or mayhave digital output. Further, the conditioning may be based on the bookentitled: “Practical Design Techniques for Sensor Signal Conditioning”,by Analog Devices, Inc., 1999 (ISBN-0-916550-20-6), which isincorporated in its entirety for all purposes as if fully set forthherein. The signal conditioning may further use the any one of theschemes, components, circuits, interfaces, or manipulations described inan handbook published 2004-2012 by Measurement Computing Corporationentitled: “Data Acquisition Handbook—A Reference For DAQ And Analog &Digital Signal Conditioning”, which is incorporated in its entirety forall purposes as if fully set forth herein.

Hence, the sensor 32 output signal may be conditioned by the signalconditioning circuit. The signal conditioner converts the sensor signalsinto a form that can be converted to digital values, and may use orcomprise time, frequency, or magnitude related manipulations. The signalconditioner may be linear or non-linear, and may include an operation oran instrument amplifier, a multiplexer, a frequency converter, afrequency-to-voltage converter, a voltage-to-frequency converter, acurrent-to-voltage converter, a current loop converter, a chargeconverter, an attenuator, a sample-and-hold circuit, a peak-detector, avoltage or current limiter, a delay line or circuit, a level translator,a galvanic isolator, an impedance transformer, a linearization circuit,a calibrator, a passive or active (or adaptive) filter, an integrator, adeviator, an equalizer, a spectrum analyzer, a compressor or ade-compressor, a coder (or decoder), a modulator (or demodulator), apattern recognizer, a smoother, a noise remover, an average or RMScircuit, or any combination thereof. In the case of an analog sensor,the analog to digital (A/D) converter may be used to convert theconditioned sensor output signal to a digital sensor data.

Any element capable of measuring or responding to a physical phenomenonmay be used as the sensor 32. An appropriate sensor may be adapted for aspecific physical phenomenon, such as a sensor responsive totemperature, humidity, pressure, audio, vibration, light, motion, sound,proximity, flow rate, electrical voltage, and electrical current. Thesensor 32 may measure the amount of a property or of a physicalquantity, or the magnitude relating to a physical phenomenon, body, orsubstance. Alternatively or in addition, the sensor 32 may be used tomeasure the time derivative thereof, such as the rate of change of theamount, the quantity or the magnitude. In the case of space relatedquantity or magnitude, a sensor may measure the linear density, surfacedensity, or volume density, relating to the amount of property pervolume. Alternatively or in addition, the sensor 32 may measure the flux(or flow) of a property through a cross-section or surface boundary, theflux density, or the current. In the case of a scalar field, a sensormay measure the quantity gradient. The sensor 32 may measure the amountof property per unit mass or per mole of substance. A single sensor maybe used to measure two or more phenomena.

The sensor 32 may directly or indirectly measure the rate of change ofthe physical quantity (gradient) versus the direction around aparticular location, or between different locations. For example, atemperature gradient may describe the differences in the temperaturebetween different locations. Further, the sensor 32 may measuretime-dependent or time-manipulated values of the phenomenon, such astime-integrated, average or Root Mean Square (RMS or rms), relating tothe square root of the mean of the squares of a series of discretevalues (or the equivalent square root of the integral in a continuouslyvarying value). Further, a parameter relating to the time dependency ofa repeating phenomenon may be measured, such as the duty-cycle, thefrequency (commonly measured in Hertz—Hz) or the period. A sensor may bebased on the Micro Electro-Mechanical Systems—MEMS (a.k.a.Micro-mechanical electrical systems) technology. The sensor 32 mayrespond to environmental conditions such as temperature, humidity,noise, vibration, fumes, odors, toxic conditions, dust, and ventilation.

The sensor 32 may be an active sensor, requiring an external source ofexcitation. For example, resistor-based sensors such as thermistors andstrain gages are active sensors, requiring a current to pass throughthem in order to determine the resistance value, corresponding to themeasured phenomenon. Similarly, a bridge circuit based sensors areactive sensors depending or external electrical circuit for theiroperation. A sensor may be a passive sensor, generating an electricaloutput without requiring any external circuit or any external voltage orcurrent. Thermocouples and photodiodes are examples or passive sensors.

The sensor 32 may measure the amount of a property or of a physicalquantity or the magnitude relating to a physical phenomenon, body orsubstance. Alternatively or in addition, a sensor may be used to measurethe time derivative thereof, such as the rate of change of the amount,the quantity or the magnitude. In the case of space related quantity ormagnitude, a sensor may measure the linear density, relating to theamount of property per length, a sensor may measure the surface density,relating to the amount of property per area, or a sensor may measure thevolume density, relating to the amount of property per volume.Alternatively or in addition, a sensor may measure the amount ofproperty per unit mass or per mole of substance. In the case of a scalarfield, the sensor 32 may further measure the quantity gradient, relatingto the rate of change of property with respect to position.Alternatively or in addition, the sensor 32 may measure the flux (orflow) of a property through a cross-section or surface boundary.Alternatively or in addition, the sensor 32 may measure the fluxdensity, relating to the flow of property through a cross-section perunit of the cross-section, or through a surface boundary per unit of thesurface area. Alternatively or in addition, the sensor 32 may measurethe current, relating to the rate of flow of property through across-section or a surface boundary, or the current density, relating tothe rate of flow of property per unit through a cross-section or asurface boundary. The sensor 32 may include or consists of a transducer,defined herein as a device for converting energy from one form toanother for the purpose of measurement of a physical quantity or forinformation transfer. Further, a single sensor may be used to measuretwo or more phenomena. For example, two characteristics of the sameelement may be measured, each characteristic corresponding to adifferent phenomenon.

A sensor output may have multiple states, where the sensor state isdepending upon the measured parameter of the sensed phenomenon. Thesensor 32 may be based on a two state output (such as ‘0’ or ‘1’, or‘true’ and ‘false’), such as an electric switch having two contacts,where the contacts can be in one of two states: either “closed” meaningthe contacts are touching and electricity can flow between them, or“open”, meaning the contacts are separated and the switch isnon-conducting. The sensor 32 may be a threshold switch, where theswitch changes its state upon sensing that the magnitude of the measuredparameter of a phenomenon exceeds a certain threshold. For example, thesensor 32 may be a thermostat is a temperature-operated switch used tocontrol a heating process. Another example is a voice operated switch(a.k.a. VOX), which is a switch that operates when sound over a certainthreshold is detected. It is usually used to turn on a transmitter orrecorder when someone speaks and turn it off when they stop speaking.Another example is a mercury switch (also known as a mercury tiltswitch), which is a switch whose purpose is to allow or interrupt theflow of electric current in an electrical circuit in a manner that isdependent on the switch's physical position or alignment relative to thedirection of the “pull” of earth's gravity, or other inertia. Thethreshold of a threshold based switch may be fixed or settable. Further,an actuator may be used in order to locally or remotely set thethreshold level.

The sensor 32 may be an analog sensor having an analog signal outputsuch as analog voltage or current, or may have continuously variableimpedance. Alternatively on in addition, the sensor 32 may have adigital signal output. A sensor may serve as a detector, notifying onlythe presence of a phenomenon, such as by a switch, and may use a fixedor settable threshold level. The sensor 32 may measure time-dependent orspace-dependent parameters of a phenomenon. The sensor 32 may measuretime-dependencies or a phenomenon such as the rate of change,time-integrated or time-average, duty-cycle, frequency or time betweenevents. The sensor 32 may be a passive sensor, or an active sensorrequiring an external source of excitation. The sensor 32 may besemiconductor-based, and may be based on MEMS technology.

In some cases, the sensor 32 operation is based on generating a stimulusor an excitation to generate influence or create a phenomenon. Theentire or part of the generating or stimulating mechanism may be in thiscase an integral part of the sensor 32, or may be regarded asindependent actuators, and thus may be controlled by the controller.Further, the sensor 32 and an actuator, independent or integrated, maybe cooperatively operating as a set, for improving the sensing or theactuating functionality. For example, a light source, treated as anindependent actuator, may be used to illuminate a location, in order toallow an image sensor to faithfully and properly capture an image ofthat location. In another example, where a bridge is used to measureimpedance, the excitation voltage of the bridge may be supplied from apower supply treated and acting as an actuator.

The sensor 32 may respond to chemical process or may be involved influid handling, such as measuring flow or velocity. The sensor 32 may beresponsive to the location or motion such as navigational instrument, orbe used to detect or measure position, angle, displacement, distance,speed or acceleration. The sensor 32 may be responsive to mechanicalphenomenon such as pressure, force, density or level. The environmentalrelated sensor may respond to humidity, air pressure, and airtemperature. Similarly, any sensor used to detect or measure ameasurable attribute and converts it into an electrical signal may beused. Further, the sensor 32 may be a metal detector, which detectsmetallic objects by detecting their conductivity.

In one example, the sensor 32 is used to measure, sense or detect thetemperature of an object, that may be solid, liquid or gas (such as theair temperature), in a location. Such sensor 32 may be based on athermistor, which is a type of resistor whose resistance variessignificantly with temperature, and is commonly made of ceramic orpolymer material. A thermistor may be a PTC (Positive TemperatureCoefficient) type, where the resistance increases with increasingtemperatures, or may be an NTC (Negative Temperature Coefficient) type,where the resistance decreases with increasing temperatures.Alternatively (or in addition), a thermoelectric sensor may be based ona thermocouple, consisting of two different conductors (usually metalalloys), that produce a voltage proportional to a temperaturedifference. For higher accuracy and stability, an RTD (ResistanceTemperature Detector) may be used, typically consisting of a length offine wire-wound or coiled wire wrapped around a ceramic or glass core.The RTD is made of a pure material whose resistance at varioustemperatures is known (R vs. T). A common material used may be platinum,copper, or nickel. A quartz thermometer may be used as well forhigh-precision and high-accuracy temperature measurement, based on thefrequency of a quartz crystal oscillator. The temperature may bemeasured using conduction, convection, thermal radiation, or by thetransfer of energy by phase changes. The temperature may be measured indegrees Celsius (° C.) (a.k.a. Centigrade), Fahrenheit (° F.), or Kelvin(° K). In one example, the temperature sensor (or its output) is used tomeasure a temperature gradient, providing in which direction and at whatrate the temperature changes the most rapidly around a particularlocation. The temperature gradient is a dimensional quantity expressedin units of degrees (on a particular temperature scale) per unit length,such as the SI (International System of Units) unit Kelvin per meter(K/m).

In some embodiments, a measurement of affective response of a usercomprises, and/or is based on, a behavioral cue of the user. Abehavioral cue of the user is obtained by monitoring the user in orderto detect things such as facial expressions of the user, gestures madeby the user, tone of voice, and/or other movements of the user's body(e.g., fidgeting, twitching, or shaking). The behavioral cues may bemeasured utilizing various types of sensors. Some non-limiting examplesinclude an image capturing device (e.g., a camera), a movement sensor, amicrophone, an accelerometer, a magnetic sensor, and/or a pressuresensor. In one example, a behavioral cue may involve prosodic featuresof a user's speech such as pitch, volume, tempo, tone, and/or stress(e.g., stressing of certain syllables), which may be indicative of theemotional state of the user. In another example, a behavioral cue may bethe frequency of movement of a body (e.g., due to shifting and changingposture when sitting, laying down, or standing). In this example, asensor embedded in a device such as accelerometers in a smartphone orsmartwatch may be used to take the measurement of the behavioral cue.

In some embodiments, a measurement of affective response of a user maybe obtained by capturing one or more images of the user with animage-capturing device, such as a camera. Optionally, the one or moreimages of the user are captured with an active image-capturing devicethat transmits electromagnetic radiation (such as radio waves,millimeter waves, or near visible waves) and receives reflections of thetransmitted radiation from the user. Optionally, the one or morecaptured images are in two dimensions and/or in three dimensions.Optionally, the one or more captured images comprise one or more of thefollowing: a single image, sequences of images, a video clip. In oneexample, images of a user captured by the image capturing device may beutilized to determine the facial expression and/or the posture of theuser. In another example, images of a user captured by the imagecapturing device depict an eye of the user. Optionally, analysis of theimages can reveal the direction of the gaze of the user and/or the sizeof the pupils. Such images may be used for eye tracking applications,such as identifying what the user is paying attention to, and/or fordetermining the user's emotions (e.g., what intentions the user likelyhas). Additionally, gaze patterns, which may involve informationindicative of directions of a user's gaze, the time a user spends gazingat fixed points, and/or frequency at which the user changes points ofinterest, may provide information that may be utilized to determine theemotional response of the user.

In some embodiments, a measurement of affective response of a user mayinclude a physiological signal derived from a biochemical measurement ofthe user. For example, the biochemical measurement may be indicative ofthe concentration of one or more chemicals in the body of the user(e.g., electrolytes, metabolites, steroids, hormones, neurotransmitters,and/or products of enzymatic activity). In one example, a measurement ofaffective response may describe the glucose level in the bloodstream ofthe user. In another example, a measurement of affective response maydescribe the concentration of one or more stress-related hormones suchas adrenaline and/or cortisol. In yet another example, a measurement ofaffective response may describe the concentration of one or moresubstances that may serve as inflammation markers such as C-reactiveprotein (CRP). In one embodiment, a sensor that provides a biochemicalmeasurement may be an external sensor (e.g., a sensor that measuresglucose from a blood sample extracted from the user). In anotherembodiment, a sensor that provides a biochemical measurement may be inphysical contact with the user (e.g., contact lens in the eye of theuser that measures glucose levels). In yet another embodiment, a sensorthat provides a biochemical measurement may be a sensor that is in thebody of the user (an “in vivo” sensor). Optionally, the sensor may beimplanted in the body (e.g., by a chirurgical procedure), injected intothe bloodstream, and/or enter the body via the respiratory and/ordigestive system.

Sensors used to take measurements of affective response may beconsidered, in some embodiments, to be part of a Body Area Network (BAN)also called a Body Sensor Networks (BSN). Such networks enablemonitoring of user physiological signals, actions, health status, and/ormotion patterns. Further discussion about BANs may be found in Chen etal., “Body area networks: A survey” in Mobile networks and applications16.2 (2011): 171-193.

The aforementioned examples involving sensors and/or measurements ofaffective response represent an exemplary sample of possiblephysiological signals and/or behavioral cues that may be measured.Embodiments described in this disclosure may utilize measurements ofadditional types of physiological signals and/or behavioral cues, and/ortypes of measurements taken by sensors, which are not explicitly listedabove. Additionally, in some examples given above some of the sensorsand/or techniques may be presented in association with certain types ofvalues that may be obtained utilizing those sensors and/or techniques.This is not intended to be limiting description of what those sensorsand/or techniques may be used for. In particular, a sensor and/or atechnique listed above, which is associated in the examples above with acertain type of value (e.g., a certain type of physiological signaland/or behavioral cue) may be used, in some embodiments, in order toobtain another type of value, not explicitly associated with the sensorand/or technique in the examples given above.

A wirelessly communicating device 31 b is described in the arrangement40 a shown in FIG. 4a , and comprises the wireless transceiver 43, whichis typically a wireless modem, connected to the antenna 46, controlledby the controller 39, and powered from the power source 34. The antenna46 is used for transmitting and receiving over-the-air Radio-Frequency(RF) based communication signals. Commands received over the air arereceived by the antenna 46, processed by the wireless transceiver 43,and transmitted to the controller 39. Similarly, data to be wirelesslytransmitted is received at the wireless transceiver 43 from thecontroller 39, and transmitted via the antenna 46 by the wirelesstransceiver 43. For example, data may be wirelessly sent to, andcommands may be received from, the smartphone 49 over the wirelessconnection (or link), as shown in an arrangement 40 a in FIG. 4 a.

The smartphone 49 may be replaced with any device having wirelessfunctionality, and such device may consist of, be part of, or include, aPersonal Computer (PC), a desktop computer, a mobile computer, a laptopcomputer, a notebook computer, a tablet computer, a server computer, ahandheld computer, a handheld device, a Personal Digital Assistant (PDA)device, or a cellular handset. Alternatively or in addition, such adevice may consist of, be part of, or include, a handheld PDA device, anon-board device, an off-board device, a hybrid device, a vehiculardevice, a non-vehicular device, a mobile device, or a portable device.

Any function, discrete or continuous, monotonic or non-monotonic, may beapplied to the sensor output for further handling or processing. Thefunction may be an elementary function that is built from basicoperations (e.g. addition, exponentials, and logarithms) such as anAlgebraic function that can be expressed as the solution of a polynomialequation with integer coefficients, Polynomials that may be addition,multiplication, and exponentiation, such as Linear function (Firstdegree polynomial, graph is a straight line), Quadratic function (Seconddegree polynomial, graph is a parabola), Cubic function (Third degreepolynomial), Quartic function (Fourth degree polynomial), Quinticfunction (Fifth degree polynomial), Sextic function (Sixth degreepolynomial), or Rational functions (A ratio of two polynomials).Similarly, the function may be an Nth root based, such as a Square rootor a Cube root. Alternatively or in addition, a non algebraic functionmay be used, such as a Transcendental function, that may be Exponentialfunction that raises a fixed number to a variable power, Hyperbolicfunctions that uses trigonometric functions, Logarithmic function, or aPower function that raises a variable number to a fixed power. Thefunction may be a periodic function such as a trigonometric functions,that may use or include sine, cosine, tangent, cotangent, secant,cosecant, exsecant, excosecant, versine, coversine, vercosine,covercosine, haversine, hacoversine, havercosine, or hacovercosine,typically used in geometry.

The devices, systems, and methods described herein may be integratedwith, or may be part of, a smartphone, or any device having wirelessfunctionality, and such device may consist of, be part of, or include, aPersonal Computer (PC), a desktop computer, a mobile computer, a laptopcomputer, a notebook computer, a tablet computer, a server computer, ahandheld computer, a handheld device, a Personal Digital Assistant (PDA)device, or a cellular handset. Alternatively or in addition, such adevice may consist of, be part of, or include, a handheld PDA device, anon-board device, an off-board device, a hybrid device, a vehiculardevice, a non-vehicular device, a mobile device, or a portable device.When integrated with a smartphone or any other wireless device, any partof, or whole of, any of the devices or systems described herein, or anypart of, or whole of, any of the circuits of functionalities describedherein, may be added to or integrated with the smartphone or the otherwireless device, such as sharing the same enclosure, sharing the samepower supply or power source (such as a battery), sharing the same userinterface (such as a button, a display, or a touch-screen), or sharingthe same processor.

Eye blink and smile are critically important facial movements, and havetraditionally represented primary targets for functional restoration inpatients experiencing facial paralysis, with eye closure generallyregarded as the top functional priority. Surgical manipulation of theperiocular complex does provide benefit; however, it does not restorehigh-quality, synchronous, dynamic movement, and it remains invasive. Inone example, any of the methods and devices described herein may be usedto artificially stimulate eye blink and smile, spanning from rudimentaryconceptual work to indwelling stimulating electrodes, such as fortreating patients with acute facial paralysis by deliveringtranscutaneous facial nerve stimulation to induce eye closure. Further,the discomfort of using such a method may be mitigated or eliminatedwhen using such external blink restoration system. Furthermore, the vastmajority of facial paralysis is unilateral, and facial expressions aretypically symmetric, movements of the nonparalyzed side may be used toinitiate corresponding movements of the paralyzed side. Any of thedevices or methods herein may be used to detect movements on the healthyside of the face, and drive activation of contralateral paralyzedmuscles, to elicit symmetric facial expressions, replacing orcomplementing surgical facial reanimation procedures by means of facialpacing technology.

Pain is a warning and diagnostics system and the human body's method ofnotifying that something is wrong, serving as a warning signal of atrauma or malfunction in the body. The pain typically travels from theinjured area or organ along the small nerves leading to the spinal cord,where it travels up the spinal cord to the brain, where it is theninterpreted causing the pain to be felt. In one example, any of themethods and devices described herein may be used as non-invasive,drug-free method for controlling pain. Comfortable electrical impulsesare transmitted to the human body through the skin and to the nerves ina non-invasive way, in order to modify the pain perspective. While notcuring the physiological problem that causes the pain, it may help andbe effective, at least in some persons, in reducing or eliminating thepain, allowing for a return to normal activity.

While exampled herein for stimulating blinking or other eye relatedfunctionalities, any apparatus and method herein may equally be used forpatients that suffer from Dry Eye Syndrome (DES). A study thatinvestigates the association between partial blinking during spontaneousblinking as measured by interferometry and ocular exams for theassessment of dry eye disease (DED) is described in a paper entitled:“Evaluation of incomplete blinking as a measurement of dry eye disease”by Jie Y, Sella R, Feng J, Gomez M L, and Afshari N A, available athttps://www.ncbi.nlm.nih.gov/pubmed/31152804 [Ocul Surf. 2019 May 29.pii: S1542-0124(19)30104-1. doi: 10.1016/j.jtos.2019.05.007], published2019 by Elsevier Inc. This retrospective study included 58 eyes ofpatients previously diagnosed with DED. Ocular surface assessmentincluded ocular surface disease index (OSDI) score, tear filmosmolarity, tear breakup time (TBUT), grading of corneal fluoresceinstaining, Schirmer I test, and dry eye parameters by the LipiView™interferometer (TearScience, Morrisville, N.C., USA), including lipidlayer thickness of the tear film (LLT), meibomian gland dropout (MGd),number of incomplete and complete blinks per 20 s and the partialblinking rate (PBR). Generalized estimation equations (GEE) were usedfor association testing between each variable of interest. The workingcorrelation for each GEE model was selected using the CorrectedQuasi-likelihood under the Independence Model Criterion.

The number of incomplete blinks was significantly associated with TBUT(P=0.006), OSDI (P=0.000) and MGd (P=0.000). PBR was significantlyassociated with OSDI (P=0.032) and MGd (P=0.000). The number of completeblinks was significantly associated with TBUT (P=0.032), but not withother ocular surface parameters. MGd was significantly associated withTBUT (P=0.002) and OSDI (P=0.001). LLT was significantly associated withtear film osmolarity (P=0.007), and tear film osmolarity wassignificantly associated with LLT (P=0.000). Incomplete blinking isassociated with decreased TBUT, increased OSDI, and increased MGdpossibly through its contribution to meibomian gland obstruction andsubsequent loss of tear film homeostasis. It may therefore be consideredan additive measure for mild-to-moderate DED assessment.

This retrospective study included 58 eyes of patients previouslydiagnosed with DED. Ocular surface assessment included ocular surfacedisease index (OSDI) score, tear film osmolarity, tear breakup time(TBUT), grading of corneal fluorescein staining, Schirmer I test, anddry eye parameters by the LipiView™ interferometer (TearScience,Morrisville, N.C., USA), including lipid layer thickness of the tearfilm (LLT), meibomian gland dropout (MGd), number of incomplete andcomplete blinks per 20 s and the partial blinking rate (PBR).Generalized estimation equations (GEE) were used for association testingbetween each variable of interest. The working correlation for each GEEmodel was selected using the Corrected Quasi-likelihood

under the Independence Model Criterion. The number of incomplete blinkswas significantly associated with TBUT (P=0.006), OSDI (P=0.000) and MGd(P=0.000). PBR was significantly associated with OSDI (P=0.032) and MGd(P=0.000). The number of complete blinks was significantly associatedwith TBUT (P=0.032), but not with other ocular surface parameters. MGdwas significantly associated with TBUT (P=0.002) and OSDI (P=0.001). LLTwas significantly associated with tear film osmolarity (P=0.007), andtear film osmolarity was significantly associated with LLT (P=0.000).Conclusions—Incomplete blinking is associated with decreased TBUT,increased OSDI, and increased MGd possibly through its contribution tomeibomian gland obstruction and subsequent loss of tear filmhomeostasis. It may, therefore, be considered an additive measure formild-to-moderate DED assessment.

While exampled herein for aesthetics and dry-eye purposes, any apparatusand method herein may equally be used for physiographic purposes, wherethe stimulated blinking may be used to strengthen the facial (or other)muscles, for example to elongate the time for ALS patients tocommunicate.

Further, while exampled herein for stimulating blinking or other eyerelated functionalities, any apparatus and method herein may equally beused for stimulating other human body muscles, such as other facialmuscles. For example, such as by using different electrodes location,any apparatus and method herein may be used to elicit a smile, such asby stimulating the mouth related muscles by applying electrical currentto the respective nerves. The loss of facial expression and thedisfigurement of facial paralysis have serious implications for apatient's physical and psychological well-being. Numerous aetiologies offacial paralysis exist but once nerve recovery has been static for twoyears, interventional surgery is required to improve the situation.Facial paralysis is often treated as an aesthetic problem but can alsohave real physical and psychological problems. These include difficultywith speech, low self-esteem, poor social interaction, oralincontinence, and dental problems; caries may develop due to the lack offood progression through the oral cavity and repeated trauma andulceration caused by biting of the inside of the paralysed cheek. Poorunderstanding of the treatment modalities available and an element of‘postcode lottery’ have an impact on the service a patient may receive.Smile Restoration is described in a paper entitled: “Smile Restorationfor Permanent Facial Paralysis”, by Jonathan Leckenby and AdriaanGrobbelaar (both of the Department of Plastic Surgery, The Royal FreeHospital, University of London, London, UK), Published 2013 by TheKorean Society of Plastic and Reconstructive Surgeons, [pISSN:2234-6163●eISSN: 2234-6171, http://dx.doi.org/10.5999/aps.2013.40.5.633,Arch Plast Surg 2013;40:633-638], which is incorporated in its entiretyfor all purposes as if fully set forth herein.

While exampled herein for stimulating blinking or other eye relatedfunctionalities for overcoming temporary or permanent facial nerveacute, such as Bell's palsy, any apparatus and method herein may equallybe used for patients where stimulated blinking may be beneficial, suchas for blinking deficiency or dry eye that results from Parkinson'sDisease (PD), ALS (Amyotrophic Lateral Sclerosis), Stroke, Lyme disease,Ramsay Hunt syndrome type 2, also known as herpes zoster oticus, Moebiussyndrome, Melkersson-Rosenthal syndrome, Guillain-Barré Syndrome (GBS),Sarcoidosis, or Sjögren syndrome (SjS, SS), as explained below.

-   a. Parkinson's Disease (PD). Parkinson's Disease (PD) belongs to a    group of conditions called motor system disorders, which are the    result of the loss of dopamine-producing brain cells. The four    primary symptoms of PD are tremor, or trembling in hands, aims,    legs, jaw, and face; rigidity, or stiffness of the limbs and trunk;    bradykinesia, or slowness of movement; and postural instability, or    impaired balance and coordination. As these symptoms become more    pronounced, patients may have difficulty walking, talking, or    completing other simple tasks. PD usually affects people over the    age of 60. Symptoms of PD are subtle and occur gradually. In some    people the disease progresses more quickly than in others. As the    disease progresses, the shaking, or tremor, which affects the    majority of people with PD may begin to interfere with daily    activities. Other symptoms may include depression and other    emotional changes; difficulty in swallowing, chewing, and speaking;    urinary problems or constipation; skin problems; and sleep    disruptions. There are currently no blood or laboratory tests that    have been proven to help in diagnosing sporadic PD. Therefore the    diagnosis is based on medical history and a neurological    examination. The disease can be difficult to diagnose accurately.    Doctors may sometimes request brain scans or laboratory tests in    order to rule out other diseases.

Hypomimia is a common and early symptom of Parkinson's disease (PD),which reduces the ability of PD patients in manifesting emotions, and itis visually evaluated by the neurologist during neurologicalexaminations for PD diagnosis as described in task 3.2 of the MovementDisorder Society—Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Apaper entitled: “Objective assessment of blinking and facial expressionsin Parkinson's disease using vertical electrooculogram and facialsurface electromyography” by Carlo Maremmani, Roberto Monastero,Giovanni Orlandi, Stefano Salvadori, Aldo Pieroni, Roberta Baschi,Alessandro Pecori, Cristina Dolciotti, Giulia Berchina, Erika Rovini,Flavia Cuddemi and Filippo Cavallo [Accepted Manuscript online 24 Apr.2019 athttps://www.ncbi.nlm.nih.gov/m/pubmed/31018181/?i=5&from=eye%20blink%20and%20disease]aims to measure physiological parameters related to eye blink and facialexpressions extracted from vertical electrooculogram (VEOG) and facialsurface electromyography (fsEMG) for differentiating PD patients fromhealthy control subjects (HC), since such evaluation issemi-quantitative and affected by inter-variability. The spontaneous eyeblink rate-minute (sEBR), its maximum amplitude (BMP), and facialcutaneous muscles activity were measured in 24 PD patients and 24 HCwhile the subjects looked at a visual-tester composed by three mainparts: static vision, dynamic vision, and reading silently. Specificityand sensitivity for each parameter were calculated. The VEOG and thefsEMG allowed identifying some parameters related to eye blink andfacial expressions (i.e., sEBR, BMP, frontal and peribuccal muscularactivities) able to distinguish between PD patients and HC with highsensitivity and specificity. Significance—The demonstration that thecombination of parameters related to eye blink and facial expressionscan discriminate with high accuracy PD patients versus HC, thusresulting in a useful tool to support the neurologist in objectiveassessment of hypomimia for improving PD diagnosis

A study that provides preliminary evidence regarding the utility ofcontinuous EBR monitoring for the non-invasive evaluation of the motorstatus in patients with PD, is described in a paper entitled: “UsingSpontaneous Eye-blink Rates to Predict the Motor Status of Patients withParkinson's Disease” by Hirotaka Iwaki , Hiroyuki Sogo, Haruhiko Morita,Noriko Nishikawa, Rina Ando, Noriyuki Miyaue, Satoshi Tada, Hayato Yabe,Masahiro Nagai and Masahiro Nomoto, published 2019 in Internal Medicine[doi: 10.2169/internalmedicine.1960-18 Intern Med 58: 1417-1421, 2019],which is incorporated in its entirety for all purposes as if fully setforth herein. Assessing daily motor fluctuations is an important part ofthe disease management for patients with Parkinson's disease (PD).However, the frequent recording of subjective and/or objectiveassessments is not always feasible, and easier monitoring methods havebeen sought. Previous studies have reported that the spontaneouseye-blink rate (EBR) is correlated with the dopamine levels in thebrain. Thus, the continuous monitoring of the EBR may be useful forpredicting the motor status in patients with PD. MethodsElectrooculograms (EOGs) were recorded for up to 7.5 hours from three PDpatients using a wearable device that resembled ordinary glasses. Areceiver operating characteristic (ROC) analysis was performed tocompare the ability of the EBR estimates at each time-point (BlinkIndex) and the plasma levodopa levels to predict the motor status.Results—The Blink Index was correlated with the plasma levodopa levels.When an indicator for the first hour of the observation period wasincluded in the model, the Blink Index discerned wearing-off anddyskinesia as accurately as the plasma levodopa level.

Dry eye is an important problem in Parkinson's disease (PD) with apotential to affect life quality. Tear osmolarity, accepted as the goldstandard in dry eye diagnosis, has not been studied in this subset ofpatients so far. A study that evaluates tear osmolarity, Schirmer's testscores and tear film break-up time (TBUT) in PD patients is described ina paper entitled: “Tear Osmolarity, Break-up Time and Schirmer's Scoresin Parkinson's Disease” by Turk J. Ophthalmol Published online Aug. 5,2015 [doi: 10.4274/tjo.46547, 2015 August; 45(4): 142-145 PMC—USNational Library of Medicine National Institutes of Health], which isincorporated in its entirety for all purposes as if fully set forthherein. The results show that BR and Schirmer's scores decreasedsignificantly in PD patients. Although not significant, the demonstratedtear osmolarity increment might be important to document the dry eye andinflammatory process of the ocular surface in PD patients. Materials andMethods—PD patients with a minimum follow-up of 1 year and healthycontrols who admitted for refractive abnormalities were enrolled to thestudy. Subjects using any systemic medication with a possibility toaffect tear tests were not included in the study. The presence of anyocular surface disorder, previous ocular surgery, previous dry eyediagnosis, any topical ophthalmic medication or contact lens use wereother exclusion criteria. Age, gender, disease duration, and Hoehn andYahr (H&Y) score for disease severity were noted, and blink rate (BR),Schirmer's test score, TBUT and tear osmolarity of the right eye weremeasured in both groups. Results—Thirty-seven PD patients and 37controls were enrolled to the study. The groups were age and gendermatched. The mean disease duration and H&Y score were 5.70±2.64 yearsand 1.70±0.93, respectively. H&Y staging and disease duration were notcorrelated to BR, Schirmer's scores, TBUT, or tear osmolarity (p>0.05).The mean BR was 8.54±4.99 blinks/minute in PD patients and 11.97±6.36blinks/minute in the control group. Mean Schirmer's scores, TBUT andosmolarity values were 9.08±4.46 mm, 11.38±4.05 seconds and 306.43±12.63mOsm/L in the PD group and 17.16±9.57 mm, 12.81±3.66 seconds and303.81±16.13 mOsm/L in the control group. The differences weresignificant only in BR and Schirmer's scores.

-   b. ALS. Amyotrophic Lateral Sclerosis (ALS), also known as motor    neurone disease (MND) or Lou Gehrig's disease, is a specific disease    that causes the death of neurons controlling voluntary muscles. Some    also use the term motor neuron disease for a group of conditions of    which ALS is the most common. ALS is characterized by stiff muscles,    muscle twitching, and gradually worsening weakness due to muscles    decreasing in size. It may begin with weakness in the arms or legs,    or with difficulty speaking or swallowing. About half of the people    affected develop at least mild difficulties with thinking and    behavior and most people experience pain. Most eventually lose the    ability to walk, use their hands, speak, swallow, and breathe. The    cause is not known in 90% to 95% of cases, but is believed to    involve both genetic and environmental factors. The remaining 5-10%    of cases are inherited from a person's parents. About half of these    genetic cases are due to one of two specific genes. The underlying    mechanism involves damage to both upper and lower motor neurons. The    diagnosis is based on a person's signs and symptoms, with testing    done to rule out other potential causes.

No cure for ALS is known. The goal of treatment is to improve symptoms.A medication called riluzole may extend life by about two to threemonths. Non-invasive ventilation may result in both improved quality andlength of life. Mechanical ventilation can prolong survival but does notstop disease progression. A feeding tube may help. The disease canaffect people of any age, but usually starts around the age of 60 and ininherited cases around the age of 50. The average survival from onset todeath is two to four years, though this can vary. About 10% survivelonger than 10 years. Most die from respiratory failure. In Europe, thedisease affects about two to three people per 100,000 per year. Rates inmuch of the world are unclear. In the United States, it is more commonin white people than black people. ALS patients may communicate via adedicated communication computer that is based on eye focusing,blinking, and other eye tracking functions.

Apps are beginning to appear that take advantage of Apple's True Depthcamera to provide eye gaze control on the latest iPhone or iPad Pro.There are actually two cameras; your usual selfie camera and an infraredcamera that maps your face. Eye gaze for Apple devices has been a longwished for accessibility feature. Eye gaze bars that hook up to acomputer usually cost around $2000, so that access to eye gaze and facetracking on the iPad is a big deal. News of this new technology came outat Apple's WWDC in June of 2018. Apple's ARKit 2.0 introduced an eyetracking feature. Folks quickly realized that this tool was not just foradvertisers, but could really benefit people with disabilities, such asALS. It took a few months for the first apps to follow.

An apparatus, system, and method for a mobile, low-cost headset for 3Dpoint of gaze estimation is described in U.S. Patent Application No.2015/0070470 to McMURROUGH entitled: “Apparatus, System, and Method forMobile, Low-Cost Headset for 3D Point of Gaze Estimation”, which isincorporated in its entirety for all purposes as if fully set forthherein. A point of gaze apparatus may include an eye tracking cameraconfigured to track the movements of a user's eye and a scene cameraconfigured to create a three-dimensional image and a two-dimensionalimage in the direction of the user's gaze. The point of gaze apparatusmay include an image processing module configured to identify a point ofgaze of the user and identify an object located at the user's point ofgaze by using information from the eye tracking camera and the scenecamera.

Biosensor, communicator, and/or controller apparatus, systems, andmethods for monitoring movement of a person's eye are provided in U.S.Patent Application No. 2011/0077548 to Torch entitled: “Biosensors,communicators, and controllers monitoring eye movement and methods forusing them”, which is incorporated in its entirety for all purposes asif fully set forth herein. The apparatus includes a device configured tobe worn on a user's head, a light source for directing light towards oneor both eyes of the user, one or more image guides on the device forviewing one or both eyes of the user, and one or more cameras carried onthe device and coupled to the image guides for acquiring images of theeyes and/or the user's surroundings. The apparatus may include a cableand/or a transmitter for transmitting image data from the camera to aremote location, e.g., to processor and/or display for analyzing and/ordisplaying the image data. A system including the apparatus may be usedto monitor one or more oculometric parameters, e.g., pupillary response,and/or to control a computer using the user's eyes instead of a mouse.

-   c. Stroke. A stroke is a medical condition in which poor blood flow    to the brain results in cell death. There are two main types of    stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to    bleeding. Both result in parts of the brain not functioning    properly. Signs and symptoms of a stroke may include an inability to    move or feel on one side of the body, problems understanding or    speaking, dizziness, or loss of vision to one side. Signs and    symptoms often appear soon after the stroke has occurred. If    symptoms last less than one or two hours it is known as a transient    ischemic attack (TIA) or mini-stroke. A hemorrhagic stroke may also    be associated with a severe headache. The symptoms of a stroke can    be permanent. Long-term complications may include pneumonia or loss    of bladder control.

The main risk factor for stroke is high blood pressure. Other riskfactors include tobacco smoking, obesity, high blood cholesterol,diabetes mellitus, a previous TIA, and atrial fibrillation. An ischemicstroke is typically caused by blockage of a blood vessel, though thereare also less common causes. A hemorrhagic stroke is caused by eitherbleeding directly into the brain or into the space between the brain'smembranes. Bleeding may occur due to a ruptured brain aneurysm.Diagnosis is typically based on a physical exam and supported by medicalimaging such as a CT scan or MRI scan. A CT scan can rule out bleeding,but may not necessarily rule out ischemia, which early on typically doesnot show up on a CT scan. Other tests such as an electrocardiogram (ECG)and blood tests are done to determine risk factors and rule out otherpossible causes. Low blood sugar may cause similar symptoms. Preventionincludes decreasing risk factors, as well as possibly aspirin, statins,surgery to open up the arteries to the brain in those with problematicnarrowing, and warfarin in those with atrial fibrillation. A stroke orTIA often requires emergency care. An ischemic stroke, if detectedwithin three to four and half hours, may be treatable with a medicationthat can break down the clot. Aspirin should be used. Some hemorrhagicstrokes benefit from surgery. Treatment to try to recover lost functionis called stroke rehabilitation and ideally takes place in a strokeunit; however, these are not available in much of the world.

In 2013 approximately 6.9 million people had an ischemic stroke and 3.4million people had a hemorrhagic stroke. In 2015 there were about 42.4million people who had previously had a stroke and were still alive.Between 1990 and 2010 the number of strokes which occurred each yeardecreased by approximately 10% in the developed world and increased by10% in the developing world. In 2015, stroke was the second mostfrequent cause of death after coronary artery disease, accounting for6.3 million deaths (11% of the total). About 3.0 million deaths resultedfrom ischemic stroke while 3.3 million deaths resulted from hemorrhagicstroke. About half of people who have had a stroke live less than oneyear. Overall, two thirds of strokes occurred in those over 65 yearsold. Other stroke statistics may be found athttp://www.strokecenter.org/patients/about-stroke/stroke-statistics/.Post stroke conditions are described inhttps://www.stroke.org/we-can-help/survivors/stroke-recovery/post-stroke-conditions/physical/.

-   d. Lyme disease. Lyme disease, also known as Lyme borreliosis, is an    infectious disease caused by a bacterium named Borrelia spread by    ticks. The most common sign of infection is an expanding area of    redness on the skin, known as erythema migrans, that appears at the    site of the tick bite about a week after it occurred. The rash is    typically neither itchy nor painful. Approximately 70-80% of    infected people develop a rash. Other early symptoms may include    fever, headache and tiredness. If untreated, symptoms may include    loss of the ability to move one or both sides of the face, joint    pains, severe headaches with neck stiffness, or heart palpitations,    among others. Months to years later, repeated episodes of joint pain    and swelling may occur. Occasionally, people develop shooting pains    or tingling in their arms and legs. Despite appropriate treatment,    about 10 to 20% of people develop joint pains, memory problems, and    tiredness for at least six months.

Lyme disease is transmitted to humans by the bites of infected ticks ofthe genus Ixodes. In the United States, ticks of concern are usually ofthe Ixodes scapularis type, and must be attached for at least 36 hoursbefore the bacteria can spread. In Europe ticks of the Ixodes ricinustype may spread the bacteria more quickly. In North America, Borreliaburgdorferi and Borrelia mayonii are the cause. In Europe and Asia, thebacteria Borrelia afzelii and Borrelia garinii are also causes of thedisease. The disease does not appear to be transmissible between people,by other animals, or through food. Diagnosis is based upon a combinationof symptoms, history of tick exposure, and possibly testing for specificantibodies in the blood. Blood tests are often negative in the earlystages of the disease. Testing of individual ticks is not typicallyuseful.

Prevention includes efforts to prevent tick bites such as by wearingclothing to cover the arms and legs, and using DEET-based insectrepellents. Using pesticides to reduce tick numbers may also beeffective. Ticks can be removed using tweezers. If the removed tick wasfull of blood, a single dose of doxycycline may be used to preventdevelopment of infection, but is not generally recommended sincedevelopment of infection is rare. If an infection develops, a number ofantibiotics are effective, including doxycycline, amoxicillin, andcefuroxime. Standard treatment usually lasts for two or three weeks.Some people develop a fever and muscle and joint pains from treatmentwhich may last for one or two days. In those who develop persistentsymptoms, long-term antibiotic therapy has not been found to be useful.

Lyme disease is the most common disease spread by ticks in the NorthernHemisphere. It is estimated to affect 300,000 people a year in theUnited States and 65,000 people a year in Europe. Infections are mostcommon in the spring and early summer. Lyme disease was diagnosed as aseparate condition for the first time in 1975 in Old Lyme, Conn. It wasoriginally mistaken for juvenile rheumatoid arthritis. The bacteriuminvolved was first described in 1981 by Willy Burgdorfer. Chronicsymptoms following treatment are well described and are known aspost-treatment Lyme disease syndrome (PTLDS). PTLDS is different fromchronic Lyme disease; a term no longer supported by the scientificcommunity and used in different ways by different groups. Somehealthcare providers claim that PTLDS is caused by persistent infection,but this is not believed to be true because of the inability to detectinfectious organisms after standard treatment. A vaccine for Lymedisease was marketed in the United States between 1998 and 2002, but waswithdrawn from the market due to poor sales. Research is ongoing todevelop new vaccines.

-   e. Ramsay Hunt syndrome type 2. Ramsay Hunt syndrome type 2, also    known as herpes zoster oticus, is a disorder that is caused by the    reactivation of varicella zoster virus in the geniculate ganglion, a    nerve cell bundle of the facial nerve. Ramsay Hunt syndrome type 2    typically presents with inability to move many facial muscles, pain    in the ear, taste loss on the front of the tongue, dry eyes and    mouth, and a vesicular rash. The symptoms and signs include acute    facial nerve paralysis, pain in the ear, taste loss in the front    two-thirds of the tongue, dry mouth and eyes, and an erythematous    vesicular rash in the ear canal, the tongue, and/or hard palate.    Since the vestibulocochlear nerve is in proximity to the geniculate    ganglion, it may also be affected, and patients may also suffer from    tinnitus, hearing loss, and vertigo. Involvement of the trigeminal    nerve can cause numbness of the face. Ramsay Hunt syndrome type 2    refers to shingles of the geniculate ganglion. After initial    infection, varicella zoster virus lies dormant in nerve cells in the    body, where it is kept in check by the immune system. Given the    opportunity, for example during an illness that suppresses the    immune system, the virus travels to the end of the nerve cell, where    it causes the symptoms described above.

The affected ganglion is responsible for the movements of facialmuscles, the touch sensation of a part of ear and ear canal, the tastefunction of the frontal two-thirds of the tongue, and the moisturizationof the eyes and the mouth. The syndrome specifically refers to thecombination of this entity with weakness of the muscles activated by thefacial nerve. In isolation, the latter is called Bell's palsy. However,as with shingles, the lack of lesions does not definitely exclude theexistence of a herpes infection. Even before the eruption of vesicles,varicella zoster virus can be detected from the skin of the ear.Shingles is prevented by immunizing against the causal virus, varicellazoster, for example through Zostavax, a stronger version of chickenpoxvaccine.

-   f. Moebius syndrome. Moebius syndrome is a rare neurological    condition that primarily affects the muscles that control facial    expression and eye movement. The signs and symptoms of this    condition are present from birth. Weakness or paralysis of the    facial muscles is one of the most common features of Moebius    syndrome. Affected individuals lack facial expressions; they cannot    smile, frown, or raise their eyebrows. The muscle weakness also    causes problems with feeding that become apparent in early infancy.    Many people with Moebius syndrome are born with a small chin    (micrognathia) and a small mouth (microstomia) with a short or    unusually shaped tongue. The roof of the mouth may have an abnormal    opening (cleft palate) or be high and arched. These abnormalities    contribute to problems with speech, which occur in many children    with Moebius syndrome. Dental abnormalities, including missing and    misaligned teeth, are also common. Moebius syndrome also affects    muscles that control back-and-forth eye movement. Affected    individuals must move their head from side to side to read or follow    the movement of objects. People with this disorder have difficulty    making eye contact, and their eyes may not look in the same    direction (strabismus). Additionally, the eyelids may not close    completely when blinking or sleeping, which can result in dry or    irritated eyes.

Other features of Moebius syndrome can include bone abnormalities in thehands and feet, weak muscle tone (hypotonia), and hearing loss. Affectedchildren often experience delayed development of motor skills (such ascrawling and walking), although most eventually acquire these skills.Some research studies have suggested that children with Moebius syndromeare more likely than unaffected children to have characteristics ofautism spectrum disorders, which are a group of conditions characterizedby impaired communication and social interaction. However, recentstudies have questioned this association. Because people with Moebiussyndrome have difficulty with eye contact and speech due to theirphysical differences, autism spectrum disorders can be difficult todiagnose in these individuals. Moebius syndrome may also be associatedwith a somewhat increased risk of intellectual disability; however, mostaffected individuals have normal intelligence.

-   g. Melkersson-Rosenthal syndrome. Melkersson-Rosenthal syndrome is a    rare neurological disorder characterized by recurring facial    paralysis, swelling of the face and lips (usually the upper    lip—cheilitis granulomatosis) and the development of folds and    furrows in the tongue (fissured tongue). Onset is in childhood or    early adolescence. After recurrent attacks (ranging from days to    years in between), swelling may persist and increase, eventually    becoming permanent. The lip may become hard, cracked, and fissured    with a reddish-brown discoloration. The cause of    Melkersson-Rosenthal syndrome is unknown, but there may be a genetic    predisposition. It has been noted to be especially prevalent among    certain ethnic groups in Bolivia. It can be symptomatic of Crohn's    disease or sarcoidosis. Approximately 400 cases have been reported    worldwide.

Diagnosis is mainly based on clinical features. However, biopsy has beenuseful in diagnosis as well as in differentiating between the differenttypes of the disease. Treatment is symptomatic and may includenonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids toreduce swelling, antibiotics and immunosuppressants. Surgery may beindicated to relieve pressure on the facial nerves and reduce swelling,but its efficacy is uncertain. Massage and electrical stimulation mayalso be prescribed. Melkersson-Rosenthal syndrome may recurintermittently after its first appearance. It can become a chronicdisorder. Follow-up care should exclude the development of Crohn'sdisease or sarcoidosis.

-   h. Guillain-Barré Syndrome (GBS). Guillain-Barré syndrome (GBS) is a    rapid-onset muscle weakness caused by the immune system damaging the    peripheral nervous system. The initial symptoms are typically    changes in sensation or pain along with muscle weakness, beginning    in the feet and hands. This often spreads to the arms and upper    body, with both sides being involved. The symptoms develop over    hours to a few weeks. During the acute phase, the disorder can be    life-threatening, with about 15% developing weakness of the    breathing muscles requiring mechanical ventilation. Some are    affected by changes in the function of the autonomic nervous system,    which can lead to dangerous abnormalities in heart rate and blood    pressure. The cause is unknown. The underlying mechanism involves an    autoimmune disorder in which the body's immune system mistakenly    attacks the peripheral nerves and damages their myelin insulation.    Sometimes this immune dysfunction is triggered by an infection or,    less commonly by surgery and rarely by vaccination. The diagnosis is    usually made based on the signs and symptoms, through the exclusion    of alternative causes, and supported by tests such as nerve    conduction studies and examination of the cerebrospinal fluid. There    are a number of subtypes based on the areas of weakness, results of    nerve conduction studies and the presence of certain antibodies. It    is classified as an acute polyneuropathy.

In those with severe weakness, prompt treatment with intravenousimmunoglobulins or plasmapheresis, together with supportive care, willlead to good recovery in the majority of people. Recovery may take weeksto years. About a third have some permanent weakness. Globally, deathoccurs in about 7.5% of those affected. Guillain-Barré syndrome is rare,at one or two cases per 100,000 people every year. Both sexes and allparts of the world have similar rates of disease. The first symptoms ofGuillain-Barré syndrome are numbness, tingling, and pain, alone or incombination. This is followed by weakness of the legs and arms thataffects both sides equally and worsens over time. The weakness can takehalf a day to over two weeks to reach maximum severity, and then becomessteady. In one in five people, the weakness continues to progress for aslong as four weeks. The muscles of the neck may also be affected, andabout half experience involvement of the cranial nerves which supply thehead and face; this may lead to weakness of the muscles of the face,swallowing difficulties and sometimes weakness of the eye muscles. In8%, the weakness affects only the legs (paraplegia or paraparesis).Involvement of the muscles that control the bladder and anus is unusual.In total, about a third of people with Guillain-Barré syndrome continueto be able to walk. Once the weakness has stopped progressing, itpersists at a stable level (“plateau phase”) before improvement occurs.The plateau phase can take between two days and six months, but the mostcommon duration is a week. Pain-related symptoms affect more than half,and include back pain, painful tingling, muscle pain and pain in thehead and neck relating to irritation of the lining of the brain.

Many people with Guillain-Barré syndrome have experienced the signs andsymptoms of an infection in the 3-6 weeks prior to the onset of theneurological symptoms. This may consist of upper respiratory tractinfection (rhinitis, sore throat) or diarrhea. In children, particularlythose younger than six years old, the diagnosis can be difficult and thecondition is often initially mistaken (sometimes for up to two weeks)for other causes of pains and difficulty walking, such as viralinfections, or bone and joint problems. On neurological examination,characteristic features are the reduced strength of muscles and reducedor absent tendon reflexes (hypo- or areflexia, respectively). However, asmall proportion have normal reflexes in affected limbs beforedeveloping areflexia, and some may have exaggerated reflexes. In theMiller Fisher variant of Guillain-Barré syndrome (see below), a triad ofweakness of the eye muscles, abnormalities in coordination, as well asabsent reflexes can be found. The level of consciousness is normallyunaffected in Guillain-Barré syndrome, but the Bickerstaff brainstemencephalitis subtype may feature drowsiness, sleepiness, or coma

Directly assessing nerve conduction of electrical impulses can excludeother causes of acute muscle weakness, as well as distinguish thedifferent types of Guillain-Barré syndrome. Needle electromyography(EMG) and nerve conduction studies may be performed. In the first twoweeks, these investigations may not show any abnormality.Neurophysiology studies are not required for the diagnosis. Formalcriteria exist for each of the main subtypes of Guillain-Barré syndrome(AIDP and AMAN/AMSAN, see below), but these may misclassify some cases(particularly where there is reversible conduction failure) andtherefore changes to these criteria have been proposed. Sometimes,repeated testing may be helpful.

-   i. Sarcoidosis. Sarcoidosis is a disease involving abnormal    collections of inflammatory cells that form lumps known as    granulomas. The disease usually begins in the lungs, skin, or lymph    nodes. Less commonly affected are the eyes, liver, heart, and brain.    Any organ, however, can be affected. The signs and symptoms depend    on the organ involved. Often, no, or only mild, symptoms are seen.    When it affects the lungs, wheezing, coughing, shortness of breath,    or chest pain may occur. Some may have Lofgren syndrome with fever,    large lymph nodes, arthritis, and a rash known as erythema nodosum.

The cause of sarcoidosis is unknown. Some believe it may be due to animmune reaction to a trigger such as an infection or chemicals in thosewho are genetically predisposed. Those with affected family members areat greater risk. Diagnosis is partly based on signs and symptoms, whichmay be supported by biopsy. Findings that make it likely include largelymph nodes at the root of the lung on both sides, high blood calciumwith a normal parathyroid hormone level, or elevated levels ofangiotensin converting enzyme in the blood. The diagnosis should only bemade after excluding other possible causes of similar symptoms such astuberculosis.

Sarcoidosis may resolve without any treatment within a few years.However, some people may have long-term or severe disease. Some symptomsmay be improved with the use of anti-inflammatory drugs such asibuprofen. In cases where the condition causes significant healthproblems, steroids such as prednisone are indicated. Medications such asmethotrexate, chloroquine, or azathioprine may occasionally be used inan effort to decrease the side effects of steroids. The risk of death is1-7%. The chance of the disease returning in someone who has had itpreviously is less than 5%. In 2015, pulmonary sarcoidosis andinterstitial lung disease affected 1.9 million people globally and theyresulted in 122,000 deaths. It is most common in Scandinavians, butoccurs in all parts of the world. In the United States risk is greateramong black as opposed to white people. It usually begins between theages of 20 and 50. It occurs more often in women than men. Sarcoidosiswas first described in 1877 by the English doctor Jonathan Hutchinson asa nonpainful skin disease.

Sarcoidosis is a systemic inflammatory disease that can affect anyorgan, although it can be asymptomatic and is discovered by accident inabout 5% of cases. Common symptoms, which tend to be vague, includefatigue (unrelieved by sleep; occurs in 66% of cases), lack of energy,weight loss, joint aches and pains (which occur in about 70% ofcases),arthritis (14-38% of persons), dry eyes, swelling of the knees,blurry vision, shortness of breath, a dry, hacking cough, or skinlesions. Less commonly, people may cough up blood. The cutaneoussymptoms vary, and range from rashes and noduli (small bumps) toerythema nodosum, granuloma annulare, or lupus pernio. Sarcoidosis andcancer may mimic one another, making the distinction difficult. Thecombination of erythema nodosum, bilateral hilar lymphadenopathy, andjoint pain is called Lofgren syndrome, which has a relatively goodprognosis. This form of the disease occurs significantly more often inScandinavian patients than in those of non-Scandinavian origin.

Any of the components of the nervous system can be involved. Sarcoidosisaffecting the nervous system is known as neurosarcoidosis. Cranialnerves are most commonly affected, accounting for about 5-30% ofneurosarcoidosis cases, and peripheral facial nerve palsy, oftenbilateral, is the most common neurological manifestation of sarcoidosis.It occurs suddenly and is usually transient. The central nervous systeminvolvement is present in 10-25% of sarcoidosis cases. Other commonmanifestations of neurosarcoidosis include optic nerve dysfunction,papilledema, palate dysfunction, neuroendocrine changes, hearingabnormalities, hypothalamic and pituitary abnormalities, chronicmeningitis, and peripheral neuropathy. Myelopathy, that is spinal cordinvolvement, occurs in about 16-43% of neurosarcoidosis cases and isoften associated with the poorest prognosis of the neurosarcoidosissubtypes. Whereas facial nerve palsies and acute meningitis due tosarcoidosis tend to have the most favourable prognosis, another commonfinding in sarcoidosis with neurological involvement is autonomic orsensory small-fiber neuropathy. Neuroendocrine sarcoidosis accounts forabout 5-10% of neurosarcoidosis cases and can lead to diabetesinsipidus, changes in menstrual cycle and hypothalamic dysfunction. Thelatter can lead to changes in body temperature, mood, and prolactin (seethe endocrine and exocrine section for details).

-   j. Sjögren syndrome. Sjögren syndrome (SjS, SS) is a long-term    autoimmune disease that affects the body's moisture-producing    glands. Primary symptoms are a dry mouth and dry eyes. Other    symptoms can include dry skin, vaginal dryness, a chronic cough,    numbness in the arms and legs, feeling tired, muscle and joint    pains, and thyroid problems. Those affected are at an increased risk    (5%) of lymphoma. While the exact cause is unclear, it is believed    to involve a combination of genetics and an environmental trigger    such as exposure to a virus or bacteria. It can occur independently    of other health problems (primary Sjögren syndrome) or as a result    of another connective tissue disorder (secondary Sjögren    syndrome).The inflammation that results progressively damages the    glands. Diagnosis is by biopsy of moisture-producing glands and    blood tests looking for specific antibodies. On biopsy there are    typically lymphocytes within the glands. Treatment is directed at    the person's symptoms. For dry eyes artificial tears, medications to    reduce inflammation, punctal plugs, or surgery to shut the tear    ducts, may be tried. For a dry mouth, chewing gum (preferably sugar    free), sipping water, or a saliva substitute may be used. In those    with joint or muscle pain, ibuprofen may be used. Medications that    can cause dryness, such as antihistamines, may also be stopped.

The disease was described in 1933 by Henrik Sjögren, after whom it isnamed; however, a number of earlier descriptions of people with thesymptoms exist. Between 0.2% and 1.2% of the population are affected,with half having the primary form and half the secondary form. Femalesare affected about ten times as often as males and it commonly begins inmiddle age; however, anyone can be affected. Among those without otherautoimmune disorders, life expectancy is unchanged.

The hallmark symptom of SS is dry mouth and keratoconjunctivitis sicca(dry eyes).Vaginal dryness and dry skin and dry nose may also occur.Other organs of the body may also be affected including kidneys, bloodvessels, lungs, liver, pancreas, and brain. Skin dryness in some peoplewith SS may be the result of lymphocytic infiltration into skin glands.The symptoms may develop insidiously, with the diagnosis often notconsidered for several years, because the complaints of sicca may beotherwise attributed to medications, a dry environment, aging, or may beregarded as not of severity warranting the level of investigationnecessary to establish the presence of the specific underlyingautoimmune disorder. SS can damage vital organs of the body withsymptoms that may plateau or worsen, or go into remission as with otherautoimmune diseases. Some people may experience only the mild symptomsof dry eyes and mouth, while others have symptoms of severe disease.Many patients can treat problems symptomatically. Others experienceblurred vision, constant eye discomfort, recurrent mouth infections,swollen parotid glands, dysphonia (vocal disorders includinghoarseness), and difficulty in swallowing and eating. Debilitatingfatigue and joint pain can seriously impair quality of life. Somepatients can develop renal (kidney) involvement (autoimmunetubulointerstitial nephritis) leading to proteinuria (excess protein inurine), urinary concentrating defect, and distal renal tubular acidosis.

Moisture replacement therapies such as artificial tears may ease thesymptoms of dry eyes. Some patients with more severe problems usegoggles to increase local humidity or have punctal plugs inserted tohelp retain tears on the ocular surface for a longer time. Additionally,cyclosporine (Restasis) is available by prescription to help treatchronic dry eye by suppressing the inflammation that disrupts tearsecretion. Prescription drugs are also available that help to stimulatesalivary flow, such as cevimeline (Evoxac) and pilocarpine. Salagen, amanufactured form of pilocarpine, can be used to help produce tears, aswell as saliva in the mouth and intestines. It is derived from thejaborandi plant.

Any apparatus herein, which may be any of the systems, devices, modules,or functionalities described herein, may be integrated with asmartphone. The integration may be by being enclosed in the samehousing, sharing a power source (such as a battery), using the sameprocessor, or any other integration functionality. In one example, thefunctionality of any apparatus herein, which may be any of the systems,devices, modules, or functionalities described here, is used to improve,to control, or otherwise be used by the smartphone. In one example, ameasured or calculated value by any of the systems, devices, modules, orfunctionalities described herein, is output to the smartphone device orfunctionality to be used therein. Alternatively or in addition, any ofthe systems, devices, modules, or functionalities described herein isused as a sensor for the smartphone device or functionality.

A ‘nominal’ value herein refers to a designed, expected, or targetvalue. In practice, a real or actual value is used, obtained, or exists,which varies within a tolerance from the nominal value, typicallywithout significantly affecting functioning. Common tolerances are 20%,15%, 10%, 5%, or 1% around the nominal value.

Discussions herein utilizing terms such as, for example, “processing,”“computing,” “calculating,” “determining,” “establishing”, “analyzing”,“checking”, or the like, may refer to operation(s) and/or process(es) ofa computer, a computing platform, a computing system, or otherelectronic computing device, that manipulate and/or transform datarepresented as physical (e.g., electronic) quantities within thecomputer's registers and/or memories into other data similarlyrepresented as physical quantities within the computer's registersand/or memories or other information storage medium that may storeinstructions to perform operations and/or processes.

Throughout the description and claims of this specification, the word“couple”, and variations of that word such as “coupling”, “coupled”, and“couplable”, refers to an electrical connection (such as a copper wireor soldered connection), a logical connection (such as through logicaldevices of a semiconductor device), a virtual connection (such asthrough randomly assigned memory locations of a memory device) or anyother suitable direct or indirect connections (including combination orseries of connections), for example for allowing the transfer of power,signal, or data, as well as connections formed through interveningdevices or elements.

The arrangements and methods described herein may be implemented usinghardware, software or a combination of both. The term “integration” or“software integration” or any other reference to the integration of twoprograms or processes herein refers to software components (e.g.,programs, modules, functions, processes etc.) that are (directly or viaanother component) combined, working or functioning together or form awhole, commonly for sharing a common purpose or a set of objectives.Such software integration can take the form of sharing the same programcode, exchanging data, being managed by the same manager program,executed by the same processor, stored on the same medium, sharing thesame GUI or other user interface, sharing peripheral hardware (such as amonitor, printer, keyboard and memory), sharing data or a database, orbeing part of a single package. The term “integration” or “hardwareintegration” or integration of hardware components herein refers tohardware components that are (directly or via another component)combined, working or functioning together or form a whole, commonly forsharing a common purpose or set of objectives. Such hardware integrationcan take the form of sharing the same power source (or power supply) orsharing other resources, exchanging data or control (e.g., bycommunicating), being managed by the same manager, physically connectedor attached, sharing peripheral hardware connection (such as a monitor,printer, keyboard and memory), being part of a single package or mountedin a single enclosure (or any other physical collocating), sharing acommunication port, or used or controlled with the same software orhardware. The term “integration” herein refers (as applicable) to asoftware integration, a hardware integration, or any combinationthereof.

The term “port” refers to a place of access to a device, electricalcircuit or network, where energy or signal may be supplied or withdrawn.The term “interface” of a networked device refers to a physicalinterface, a logical interface (e.g., a portion of a physical interfaceor sometimes referred to in the industry as a sub-interface—for example,such as, but not limited to a particular VLAN associated with a networkinterface), and/or a virtual interface (e.g., traffic grouped togetherbased on some characteristic—for example, such as, but not limited to, atunnel interface). As used herein, the term “independent” relating totwo (or more) elements, processes, or functionalities, refers to ascenario where one does not affect nor preclude the other. For example,independent communication such as over a pair of independent data routesmeans that communication over one data route does not affect norpreclude the communication over the other data routes.

As used herein, the term “Integrated Circuit” (IC) shall include anytype of integrated device of any function where the electronic circuitis manufactured by the patterned diffusion of trace elements into thesurface of a thin substrate of semiconductor material (e.g., Silicon),whether single or multiple die, or small or large scale of integration,and irrespective of process or base materials (including, withoutlimitation Si, SiGe, CMOS and GAs) including, without limitation,applications specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), digital processors (e.g., DSPs, CISCmicroprocessors, or RISC processors), so-called “system-on-a-chip” (SoC)devices, memory (e.g., DRAM, SRAM, flash memory, ROM), mixed-signaldevices, and analog ICs.

The circuits in an IC are typically contained in a silicon piece or in asemiconductor wafer, and commonly packaged as a unit. The solid-statecircuits commonly include interconnected active and passive devices,diffused into a single silicon chip. Integrated circuits can beclassified into analog, digital and mixed signal (both analog anddigital on the same chip). Digital integrated circuits commonly containmany of logic gates, flip-flops, multiplexers, and other circuits in afew square millimeters. The small size of these circuits allows highspeed, low power dissipation, and reduced manufacturing cost comparedwith board-level integration. Further, a multi-chip module (MCM) may beused, where multiple integrated circuits (ICs), the semiconductor dies,or other discrete components are packaged onto a unifying substrate,facilitating their use as a single component (as though a larger IC).

The term “computer-readable medium” (or “machine-readable medium”) asused herein is an extensible term that refers to any medium or anymemory, that participates in providing instructions to a processor,(such as the processor in the controller 39) for execution, or anymechanism for storing or transmitting information in a form readable bya machine (e.g., a computer). Such a medium may storecomputer-executable instructions to be executed by a processing elementand/or software, and data that is manipulated by a processing elementand/or software, and may take many forms, including but not limited to,non-volatile medium, volatile medium, and transmission medium.Transmission media includes coaxial cables, copper wire and fiberoptics. Transmission media can also take the form of acoustic or lightwaves, such as those generated during radio-wave and infrared datacommunications, or other form of propagating signals (e.g., carrierwaves, infrared signals, digital signals, etc.). Common forms ofcomputer-readable media include, for example, a floppy disk, a flexibledisk, hard disk, magnetic tape, or any other magnetic medium, a CD-ROM,any other optical medium, punch-cards, paper-tape, any other physicalmedium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM,any other memory chip or cartridge, a carrier wave as describedhereinafter, or any other medium from which a computer can read.

The term “computer” is used generically herein to describe any number ofcomputers, including, but not limited to personal computers, embeddedprocessing elements and systems, software, ASICs, chips, workstations,mainframes, etc. Any computer herein may consist of, or be part of, ahandheld computer, including any portable computer that is small enoughto be held and operated while holding in one hand or fit into a pocket.Such a device, also referred to as a mobile device, typically has adisplay screen with touch input and/or miniature keyboard. Non-limitingexamples of such devices include Digital Still Camera (DSC), Digitalvideo Camera (DVC or digital camcorder), Personal Digital Assistant(PDA), and mobile phones and Smartphones. The mobile devices may combinevideo, audio and advanced communication capabilities, such as PAN andWLAN. A mobile phone (also known as a cellular phone, cell phone and ahand phone) is a device which can make and receive telephone calls overa radio link whilst moving around a wide geographic area, by connectingto a cellular network provided by a mobile network operator. The callsare to and from the public telephone network, which includes othermobiles and fixed-line phones across the world. The Smartphones maycombine the functions of a personal digital assistant (PDA), and mayserve as portable media players and camera phones with high-resolutiontouch-screens, web browsers that can access, and properly display,standard web pages rather than just mobile-optimized sites, GPSnavigation, Wi-Fi and mobile broadband access. In addition to telephony,the Smartphones may support a wide variety of other services such astext messaging, MMS, email, Internet access, short-range wirelesscommunications (infrared, Bluetooth), business applications, gaming andphotography.

Some embodiments may be used in conjunction with various devices andsystems, for example, a Personal Computer (PC), a desktop computer, amobile computer, a laptop computer, a notebook computer, a tabletcomputer, a server computer, a handheld computer, a handheld device, aPersonal Digital Assistant (PDA) device, a cellular handset, a handheldPDA device, an on-board device, an off-board device, a hybrid device, avehicular device, a non-vehicular device, a mobile or portable device, anon-mobile or non-portable device, a wireless communication station, awireless communication device, a wireless Access Point (AP), a wired orwireless router, a wired or wireless modem, a wired or wireless network,a Local Area Network (LAN), a Wireless LAN (WLAN), a Metropolitan AreaNetwork (MAN), a Wireless MAN (WMAN), a Wide Area Network (WAN), aWireless WAN (WWAN), a Personal Area Network (PAN), a Wireless PAN(WPAN), devices and/or networks operating substantially in accordancewith existing IEEE 802.11, 802.11a, 802.11b, 802.11g, 802.11k, 802.11n,802.11r, 802.16, 802.16d, 802.16e, 802.20, 802.21 standards and/orfuture versions and/or derivatives of the above standards, units and/ordevices which are part of the above networks, one way and/or two-wayradio communication systems, cellular radio-telephone communicationsystems, a cellular telephone, a wireless telephone, a PersonalCommunication Systems (PCS) device, a PDA device which incorporates awireless communication device, a mobile or portable Global PositioningSystem (GPS) device, a device which incorporates a GPS receiver ortransceiver or chip, a device which incorporates an RFID element orchip, a Multiple Input Multiple Output (AMMO) transceiver or device, aSingle Input Multiple Output (SIMO) transceiver or device, a MultipleInput Single Output (MISO) transceiver or device, a device having one ormore internal antennas and/or external antennas, Digital Video Broadcast(DVB) devices or systems, multi-standard radio devices or systems, awired or wireless handheld device (e.g., BlackBerry, Palm Treo), aWireless Application Protocol (WAP) device, or the like.

Any system, device, module, or circuit herein may be addressable in awireless network (such as the Internet) using a digital address that maybe a MAC layer address that may be MAC-48, EUI-48, or EUI-64 addresstype, or may be a layer 3 address and may be static or dynamic IPaddress that may be IPv4 or IPv6 type address. Any system, device, ormodule herein may be further configured as a wireless repeater, such asa WPAN, WLAN, or a WWAN repeater.

As used herein, the terms “program”, “programmable”, and “computerprogram” are meant to include any sequence or human or machinecognizable steps, which perform a function. Such programs are notinherently related to any particular computer or other apparatus, andmay be rendered in virtually any programming language or environment,including, for example, C/C++, Fortran, COBOL, PASCAL, assemblylanguage, markup languages (e.g., HTML, SGML, XML, VoXML), and thelikes, as well as object-oriented environments such as the Common ObjectRequest Broker Architecture (CORBA), Java™ (including J2ME, Java Beans,etc.) and the like, as well as in firmware or other implementations.Generally, program modules include routines, programs, objects,components, data structures, etc., that perform particular tasks orimplement particular abstract data types.

The terms “task” and “process” are used generically herein to describeany type of running programs, including, but not limited to a computerprocess, task, thread, executing application, operating system, userprocess, device driver, native code, machine or other language, etc.,and can be interactive and/or non-interactive, executing locally and/orremotely, executing in foreground and/or background, executing in theuser and/or operating system address spaces, a routine of a libraryand/or standalone application, and is not limited to any particularmemory partitioning technique. The steps, connections, and processing ofsignals and information illustrated in the figures, including, but notlimited to, any block and flow diagrams and message sequence charts, maytypically be performed in the same or in a different serial or parallelordering and/or by different components and/or processes, threads, etc.,and/or over different connections and be combined with other functionsin other embodiments, unless this disables the embodiment or a sequenceis explicitly or implicitly required (e.g., for a sequence of readingthe value, processing the value: the value must be obtained prior toprocessing it, although some of the associated processing may beperformed prior to, concurrently with, and/or after the read operation).Where certain process steps are described in a particular order or wherealphabetic and/or alphanumeric labels are used to identify certainsteps, the embodiments of the invention are not limited to anyparticular order of carrying out such steps. In particular, the labelsare used merely for convenient identification of steps, and are notintended to imply, specify or require a particular order for carryingout such steps. Furthermore, other embodiments may use more or lesssteps than those discussed herein. The invention may also be practicedin distributed computing environments where tasks are performed byremote processing devices that are linked through a communicationsnetwork. In a distributed computing environment, program modules may belocated in both local and remote memory storage devices.

The corresponding structures, materials, acts, and equivalents of allmeans plus function elements in the claims below are intended to includeany structure, or material, for performing the function in combinationwith other claimed elements as specifically claimed. The description ofthe present invention has been presented for purposes of illustrationand description, but is not intended to be exhaustive or limited to theinvention in the form disclosed. The present invention should not beconsidered limited to the particular embodiments described above, butrather should be understood to cover all aspects of the invention asfairly set out in the attached claims. Various modifications, equivalentprocesses, as well as numerous structures to which the present inventionmay be applicable, will be readily apparent to those skilled in the artto which the present invention is directed upon review of the presentdisclosure.

Each of the methods or steps herein, may consist of, include, be partof, be integrated with, or be based on, a part of, or the whole of, thesteps, functionalities, or structure (such as software) described in thepublications that are incorporated in their entirety herein. Further,each of the components, devices, or elements herein may consist of,integrated with, include, be part of, or be based on, a part of, or thewhole of, the components, systems, devices or elements described in thepublications that are incorporated in their entirety herein.

All publications, standards, patents, and patent applications cited inthis specification are incorporated herein by reference as if eachindividual publication, patent, or patent application were specificallyand individually indicated to be incorporated by reference and set forthin its entirety herein.

1. A device for artificially stimulating a facial nerve at a temporalskin in a human body scalp for eliciting eye blinking as a substitute tobrain stimulating signal, for use with a network over a medium, thedevice comprising: a controllable pulse generator for generating abursts train signal; a sensor that outputs a sensor signal in responseto a physical phenomenon; a port for coupling to the medium; atransceiver coupled to the port for transmitting digital data to, andfor receiving digital data from, the network; two electrodes attachableto the human body scalp at the temporal skin and connected to the pulsegenerator for coupling bursts train signal to the human body forperiodically stimulating the facial nerve, so that when attached eliciteye blinking by stimulating the facial nerve; software and a processorfor executing the software, the processor is coupled to the sensor forreceiving the sensor signal therefrom, to the transceiver for receivingthe digital data from the network therefrom, and to control and activatethe controllable pulse generator; a power source for supplying DirectCurrent (DC) power to the controllable pulse generator, the sensor, thetransceiver, and the processor; and a single wearable enclosure housingthe pulse generator, the sensor, the transceiver, the port, theprocessor, and the power source, wherein the pulse generator iscontrolled or activated in response to the sensor signal or the receiveddigital data from the network.
 2. The device according to claim 1,further being integrated with, attached to, part of, used with, is thebasis of, or included in, a commercial available off-the-shelfTranscutaneous Electrical Nerve Stimulation (TENS) device.
 3. The deviceaccording to claim 1, wherein the sensor comprises, or consists of, aneye blink detector.
 4. The device according to claim 1, further forovercoming facial nerve paralysis or Bell's palsy.
 5. The deviceaccording to claim 1, wherein each of the bursts in the signalcomprises, or consists of, one or more asymmetrical Bi-Phasic squarecurrent or voltage pulses.
 6. The device according to claim 1, whereinthe controllable pulse generator comprises, or consists of, a continuoussignal generator and an electrically controlled switch connected inseries with the continuous signal generator output, and wherein theswitch comprises a control port that is coupled to be controlled by theprocessor.
 7. The device according to claim 1, wherein the singlewearable enclosure is wearable on the human body.
 8. The deviceaccording to claim 1, wherein the single enclosure is constructed tohave at least one of the following: a form substantially similar to thatof a standard hearing aid; a wearable element substantially similar tothose of a standard hearing aid; a shape allowing direct mounting in oron the external ear; and a form to at least in part substitute for astandard hearing aid.
 9. The device according to claim 1, wherein theelectrodes are optimized or configured to primarily serve asElectroencephalography (EEG) or an Electrocardiography (ECG) electrodes.10. The device according to claim 1, wherein the electrodes aremechanically attached or coupled to each other.
 11. The device accordingto claim 1, wherein each of the electrodes is a skin electrode thatcomprises a substantially flat and round conductive pad.
 12. The deviceaccording to claim 1, each of the electrodes is based on, comprises, orconsists of, flexible, stretchable, printed circuit.
 13. The deviceaccording to claim 1, wherein each of the electrodes is based on,comprises, or consists of, a patterned conductive material printed on anadhesive film that is attachable to a human skin.
 14. The deviceaccording to claim 1, wherein each of the electrodes is based on,comprises, or consists of, an implantable electrode.
 15. The deviceaccording to claim 1, wherein a parameter or a characteristic of thebursts train signal is set in response to digital data received from thenetwork.
 16. The device according to claim 1, further for use with aminimum or maximum value, wherein the pulse generator is activated ordeactivated in response to the sensor signal being below the minimumvalue, or wherein the pulse generator is activated or deactivated inresponse to the sensor signal being above the maximum value.
 17. Thedevice according to claim 1, wherein a parameter or a characteristic ofthe bursts train signal is set in response to the sensor signal.
 18. Thedevice according to claim 1, further operative to send a message to thenetwork.
 19. The device according to claim 1, wherein the device isaddressable in the network using a digital address.
 20. The deviceaccording to claim 1, wherein the network comprises, uses, or consistsof, a wireless network, the port comprises, uses, or consists of, anantenna for transmitting and receiving first Radio-Frequency (RF)signals over the air; and the transceiver comprises, uses, or consistsof, a wireless transceiver coupled to the antenna for wirelesslytransmitting and receiving the digital data over the air using thewireless network.
 21. The device according to claim 1, wherein thesensor is a physiological sensor that responds to parameters associatedwith the human body, and is external to the sensed body, implantedinside the sensed body, attached to the sensed body, or wearable on thesensed body.
 22. The device according to claim 1, wherein the sensor isan electric sensor that responds to an electrical characteristics orelectrical phenomenon quantity in an electrical circuit.
 23. The deviceaccording to claim 1, wherein the sensor consists of, or comprises, aphotoelectric sensor that responds to a visible or an invisible light,the invisible light is infrared, ultraviolet, X-rays, or gamma rays, andwherein the photoelectric sensor consists of, comprises, or is based onthe photoelectric or photovoltaic effect, and consists of, or comprises,a semiconductor component that consists of, or comprises, a photodiode,a phototransistor, or a solar cell.
 24. The device according to claim 1,wherein the sensor is an electroacoustic sensor that responds to anaudible or inaudible sound.
 25. The device according to claim 1, furtherintegrated with at least one of a wireless device, a notebook computer,a laptop computer, a media player, a Digital Still Camera (DSC), aDigital video Camera (DVC or digital camcorder), a Personal DigitalAssistant (PDA), a cellular telephone, a digital camera, a videorecorder, or a smartphone.
 26. The device according to claim 1, whereinthe electrodes are attached to affect or stimulate the Zygomatic branch,the Temporal Branch, or both.
 27. The device according to claim 1,wherein each of the electrodes includes a conductive area that isattached to the human face, and wherein the conductive area defines acenter point.
 28. The device according to claim 27, for use with animaginary line defined by the shortest path between a right eye and aright ear, or between a left eye and a left ear, of the human face,wherein one of the electrodes is located so that part of, most of, orall of, the conductive area is above the imaginary line.
 29. The deviceaccording to claim 28, wherein one of the electrodes is located so thatpart of, most of, or all of, the conductive area is below the imaginaryline.
 30. The device according to claim 1, further comprising anelectric sensor connectable to the electrodes for measuring anelectrical parameter by the electrodes.